A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Study identifier:D7870C00002
ClinicalTrials.gov identifier:NCT03351738
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects with Stable Coronary Heart Disease
Medical condition
Stable Coronary Heart Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
MEDI5884, Placebo
Sex
All
Actual Enrollment
133
Study type
Interventional
Age
45 Years - 80 Years
Date
Study Start Date: 13 Dec 2017
Primary Completion Date: 09 Nov 2018
Study Completion Date: 09 Nov 2018
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61. | Drug: Placebo Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61. |
| Experimental: MEDI5884 50 mg Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61. | Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61. |
| Experimental: MEDI5884 100 mg Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61. | Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61. |
| Experimental: MEDI5884 200 mg Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61. | Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61. |
| Experimental: MEDI5884 350 mg Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61. | Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61. |
| Experimental: MEDI5884 500 mg Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61. | Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61. |
Contacts
Investigators
Principal Investigator
Michael J Koren
Jacksonville Center for Clinical Research
