Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers

Study identifier:MI-CP105

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers

Medical condition

asthma

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 49 Years

Date

Study Start Date: 01 Aug 2004

Primary Completion Date: 01 Feb 2005

Study Completion Date: 01 Mar 2005

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2014 by MedImmune

Collaborators

"N/A"

Inclusion and exclusion criteria

Inclusion Criteria

- Males and females age 18 up to and including 49 years of age at the time of the first dose of
study drug
- Weight < 89 kg
- Written informed consent obtained from the volunteer
- Healthy by medical history and physical examination
- Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap,abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions
through 84 days after their dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through 84 days after their dose of study drug.
- Use of common over-the-counter medications such as topical corticosteroids, decongestants, antihistamines, analgesics, and antacids is permitted unless, in the opinion of the investigator, it would interfere with either the volunteer’s ability to complete the study or interpretation of
study results.
- Ability to complete the follow-up period of 84 days
- Willing to forego other forms of experimental treatment during the study period of 84 days

Exclusion Criteria

- Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C (100.5°F) at the start of the study
- Use of prescription medications, other than contraceptives, in the 28-day period before Study Day 0
- Blood donation in excess of 400 mL within 6 months of the time of entry into the study
- History of use of tobacco products within 3 years of Study Day 0 or history of smoking of >10 pack-years
- History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids
- History of allergic disease or reactions likely to be exacerbated by any component of the Study Drug (described in the Investigator’s Brochure)
- History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period
- Evidence of any systemic disease on physical examination
- Evidence of infection with hepatitis A, B, or C virus or HIV-1
- Receipt of immunoglobulins or blood products within 60 days of entering the study
- Receipt of any investigational drug therapy within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)
- Any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count <125,000/mm3 (or laboratory normal values); Na, K, Cl, CO2, AST, ALT, BUN, 4-hour fasting glucose, amylase, lipase, creatinine, troponin > upper limit of normal; other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant.
- Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram at the time of initial screening
- Elective surgery planned during the study period through Study Day 84
- Pregnancy (sexually active females must have a negative serum pregnancy test on the day of the first dose of the study drug, before dosing)
- Nursing mother
- The presence of any acute or chronic organ-specific condition or any concern, which in the opinion of the investigator, may interfere with the conduct or interpretation of the study

Location

MDS Pharma Services

New Orleans, Louisiana, United States

Arms	Assigned Interventions
Experimental: MEDI-528 0.3 mg/kg MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose	Biological/Vaccine: MEDI-528 0.3 mg/kg MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
Experimental: MEDI-528 1 mg/kg MEDI-528 (1 mg/kg) administered as a single, IV dose	Biological/Vaccine: MEDI-528 1 mg/kg MEDI-528 (1 mg/kg) administered as a single, IV dose
Experimental: MEDI-528 3 mg/kg MEDI-528 (3 mg/kg) administered as a single, IV dose	Biological/Vaccine: MEDI-528 3 mg/kg MEDI-528 (3 mg/kg) administered as a single, IV dose
Experimental: MEDI-528 9 mg/kg MEDI-528 (9 mg/kg) administered as a single, IV dose	Biological/Vaccine: MEDI-528 9 mg/kg MEDI-528 (9 mg/kg) administered as a single, IV dose

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 24 participants provided written informed consent and participated in the study between 13Aug2004 and 12Nov2004 at one site in New Orleans, Louisiana.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants received MEDI-528 in an open-label manner.

Reporting Groups

	Description
MEDI-528 0.3 mg
MEDI-528 1 mg
MEDI-528 3 mg
MEDI-528 9 mg

Participant Flow: Overall Study

	MEDI-528 0.3 mg	MEDI-528 1 mg	MEDI-528 3 mg	MEDI-528 9 mg
STARTED	6	6	6	6
COMPLETED	6	5	6	6
NOT COMPLETED	0	1	0	0
Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
MEDI-528 0.3 mg
MEDI-528 1 mg
MEDI-528 3 mg
MEDI-528 9 mg

Baseline Measures

	MEDI-528 0.3 mg	MEDI-528 1 mg	MEDI-528 3 mg	MEDI-528 9 mg	Total
Number of Participants [units: Participants]	6	6	6	6	24
Age Continuous [units: Years] Mean ± Standard Deviation	25.8 ± 11.1	29.8 ± 8.4	25.5 ± 8.8	30.5 ± 8.2	27.9 ± 8.9
Gender, Male/Female [units: Participants]
Male	6	1	2	2	11
Female	0	5	4	4	13

Outcome Measures

1. Primary Outcome Measure: Incidence of Adverse Events [ Time Frame: Days 0 - 84 ]

Measure Type	Primary
Measure Name	Incidence of Adverse Events
Measure Description	Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time Frame	Days 0 - 84
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Incidence of Adverse Events [units: Participants]	5	4	6	2

No statistical analysis provided for Incidence of Adverse Events

2. Primary Outcome Measure: Incidence of Abnormal Troponin Levels [ Time Frame: Days 0, 7, 14, 21, and 28 ]

Measure Type	Primary
Measure Name	Incidence of Abnormal Troponin Levels
Measure Description	Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)
Time Frame	Days 0, 7, 14, 21, and 28
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Incidence of Abnormal Troponin Levels [units: Participants]	0	0	0	0

No statistical analysis provided for Incidence of Abnormal Troponin Levels

3. Primary Outcome Measure: Incidence of Serious Adverse Events [ Time Frame: Days 0 - 84 ]

Measure Type	Primary
Measure Name	Incidence of Serious Adverse Events
Measure Description	Number of participants experiencing serious adverse events
Time Frame	Days 0 - 84
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Incidence of Serious Adverse Events [units: Participants]	0	0	0	0

No statistical analysis provided for Incidence of Serious Adverse Events

4. Secondary Outcome Measure: Incidence of Anti-drug Antibodies (ADA) to MEDI-528 [ Time Frame: Days 14, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Measure Description	Number of participants who had ADA detected at each time point
Time Frame	Days 14, 28, 42, and 84
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Incidence of Anti-drug Antibodies (ADA) to MEDI-528 [units: Participants]
Day 14	0	0	0	0
Day 28	0	0	0	0
Day 42	0	0	0	0
Day 84	0	0	1	0

No statistical analysis provided for Incidence of Anti-drug Antibodies (ADA) to MEDI-528

5. Secondary Outcome Measure: Time to Observed Maximum Serum Concentration (Tmax) [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Time to Observed Maximum Serum Concentration (Tmax)
Measure Description	Tmax of MEDI-528
Time Frame	Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Time to Observed Maximum Serum Concentration (Tmax) [units: Hours] Median (Full Range)	1.5 (0.0 to 4.0)	1.1 (0.1 to 2.1)	1.2 (0.2 to 24.2)	0.7 (0.5 to 2.6)

No statistical analysis provided for Time to Observed Maximum Serum Concentration (Tmax)

6. Secondary Outcome Measure: Observed Maximum Serum Concentration (Cmax) [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Observed Maximum Serum Concentration (Cmax)
Measure Description	Cmax of MEDI-528
Time Frame	Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Observed Maximum Serum Concentration (Cmax) [units: Micrograms per milliliter] Geometric Mean (Geometric Coefficient of Variation)	7.2 (42%)	22.2 (30%)	59.7 (25%)	231.2 (17%)

No statistical analysis provided for Observed Maximum Serum Concentration (Cmax)

7. Secondary Outcome Measure: Area Under the Concentration Curve from Time Zero to Last Measurable Concentration [AUC(0-t)] [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Area Under the Concentration Curve from Time Zero to Last Measurable Concentration [AUC(0-t)]
Measure Description	AUC(0-t) of MEDI-528
Time Frame	Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Area Under the Concentration Curve from Time Zero to Last Measurable Concentration [AUC(0-t)] [units: Micrograms times hours per milliliter] Geometric Mean (Geometric Coefficient of Variation)	2463.7 (85%)	7765.6 (55%)	26221.5 (40%)	101476.7 (16%)

No statistical analysis provided for Area Under the Concentration Curve from Time Zero to Last Measurable Concentration [AUC(0-t)]

8. Secondary Outcome Measure: Area Under the Concentration Curve from Time Zero to Infinity [AUC(0-infinity)] [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Area Under the Concentration Curve from Time Zero to Infinity [AUC(0-infinity)]
Measure Description	AUC(0-infinity) of MEDI-528
Time Frame	Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Area Under the Concentration Curve from Time Zero to Infinity [AUC(0-infinity)] [units: Microgram times hours per milliliter] Geometric Mean (Geometric Coefficient of Variation)	3982.2 (67%)	10084.6 (50%)	30035.5 (40%)	112344.3 (22%)

No statistical analysis provided for Area Under the Concentration Curve from Time Zero to Infinity [AUC(0-infinity)]

9. Secondary Outcome Measure: Percent of Total Area Under the Concentration Curve Extrapolated from Last Measurable Time to Infinity [AUC(ext)] [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Percent of Total Area Under the Concentration Curve Extrapolated from Last Measurable Time to Infinity [AUC(ext)]
Measure Description	AUC(ext) of MEDI-528
Time Frame	Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Percent of Total Area Under the Concentration Curve Extrapolated from Last Measurable Time to Infinity [AUC(ext)] [units: Percentage of Projected AUC] Geometric Mean (Geometric Coefficient of Variation)	35.8 (30%)	21.5 (30%)	10.5 (64%)	8.2 (63%)

No statistical analysis provided for Percent of Total Area Under the Concentration Curve Extrapolated from Last Measurable Time to Infinity [AUC(ext)]

10. Secondary Outcome Measure: Total Body Clearance (CL) [ Time Frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Total Body Clearance (CL)
Measure Description	CL of MEDI-528
Time Frame	Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Total Body Clearance (CL) [units: Milliter per day] Geometric Mean (Geometric Coefficient of Variation)	120.5 (51%)	160.1 (34%)	166.1 (31%)	154.6 (13%)

No statistical analysis provided for Total Body Clearance (CL)

11. Secondary Outcome Measure: Half-life (T1/2) [ Time Frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Half-life (T1/2)
Measure Description	T1/2 of MEDI-528
Time Frame	Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Half-life (T1/2) [units: Hours] Geometric Mean (Geometric Coefficient of Variation)	651.1 (24%)	559.1 (36%)	581.3 (21%)	594.9 (26%)

No statistical analysis provided for Half-life (T1/2)

12. Secondary Outcome Measure: Terminal Phase Elimination Rate (Vz) [ Time Frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ]

Measure Type	Secondary
Measure Name	Terminal Phase Elimination Rate (Vz)
Measure Description	Vz of MEDI-528
Time Frame	Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received MEDI-528

Reporting Groups

	Description
MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, IV dose
MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, IV dose

Measured Values

	MEDI-528 0.3 mg/kg	MEDI-528 1 mg/kg	MEDI-528 3 mg/kg	MEDI-528 9 mg/kg
Number of Participants Analyzed [units:participants]	6	6	6	6
Terminal Phase Elimination Rate (Vz) [units: Liters] Geometric Mean (Geometric Coefficient of Variation)	4.7 (38%)	5.4 (30%)	5.8 (19%)	5.5 (18%)

No statistical analysis provided for Terminal Phase Elimination Rate (Vz)

Serious Adverse Events

Time Frame	Days 0-84
Additional Description	No text entered.

Reporting Groups

	Description
MEDI-528 0.3 mg	No text entered.
MEDI-528 1 mg	No text entered.
MEDI-528 3 mg	No text entered.
MEDI-528 9 mg	No text entered.

Serious Adverse Events

	MEDI-528 0.3 mg	MEDI-528 1 mg	MEDI-528 3 mg	MEDI-528 9 mg
Total, serious adverse events
# participants affected / at risk	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)

Other Adverse Events

Time Frame	Days 0-84
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
MEDI-528 0.3 mg	No text entered.
MEDI-528 1 mg	No text entered.
MEDI-528 3 mg	No text entered.
MEDI-528 9 mg	No text entered.

Other Adverse Events

MEDI-528 0.3 mg

MEDI-528 1 mg

MEDI-528 3 mg

MEDI-528 9 mg

Total, other (not including serious) adverse events

# participants affected / at risk

5/6 (83.33%)

4/6 (66.67%)

6/6 (100.00%)

2/6 (33.33%)

Infections and infestations

Vaginitis bacterial¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

Blood amylase increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

Blood bicarbonate decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

2/6 (33.33%)

# events

Investigations

Blood glucose increased¹,^†

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

2/6 (33.33%)

0/6 (0.00%)

# events

Investigations

Haemoglobin decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

Lipase increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

Lymphocyte count decreased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

Protein urine present¹,^†

# participants affected / at risk

1/6 (16.67%)

2/6 (33.33%)

5/6 (83.33%)

1/6 (16.67%)

# events

Investigations

White blood cell count decreased¹,^†

# participants affected / at risk

2/6 (33.33%)

1/6 (16.67%)

0/6 (0.00%)

# events

Investigations

White blood cell count increased¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 7.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Joseph Parker, MD
Organization:	MedImmune
Phone	301-398-0000
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

MedImmune Contact

301-398-0000

clinicaltrialenquiries@medimmune.com

Investigators

Principal Investigator

Ramon Vargas

Unaffiliated

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

MDS Pharma Services

Trial Results Summaries