A study of MEDI7352 in Painful Osteoarthritis of the Knee
Study identifier:D5680C00001
ClinicalTrials.gov identifier:NCT02508155
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI7352 in Subjects with Painful Osteoarthritis of the Knee
Medical condition
Chronic Pain
Phase
Phase 1
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
129
Study type
Interventional
Age
18 Years - 80 Years
Date
Study Start Date: 29 Oct 2015
Primary Completion Date: 23 Dec 2020
Study Completion Date: 23 Dec 2020
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verification:
Verified 01 Dec 2021 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part 1 SAD phase MEDI7352 Dose 1 (IV) Participants in Part 1 of SAD phase will receive intravenous (IV) infusion of MEDI7352 Dose 1 on Day 1. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 1 SAD phase MEDI7352 Dose 2 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 2 on Day 1. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 1 SAD phase MEDI7352 Dose 3 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 3 on Day 1. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 1 SAD phase MEDI7352 Dose 4 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 4 on Day 1. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 1 SAD phase MEDI7352 Dose 5 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 5 on Day 1. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 1 SAD phase MEDI7352 Dose 6 (IV) Participants in Part 1 of SAD phase will receive IV infusion of MEDI7352 Dose 6 on Day 1. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 1 SAD phase MEDI7352 Dose 4 (SC) Participants in Part 1 of SAD phase will receive subcutaneous (SC) injection of MEDI7352 Dose 4 on Day 1. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Placebo Comparator: Part 1 SAD phase Placebo Participants in Part 1 of SAD phase will receive IV infusion of placebo matched to MEDI7352 on Day 1. | Biological/Vaccine: Placebo Participants will receive placebo matched MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 2 MAD phase MEDI7352 Dose 7 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 7 on Days 1, 15, 29, 43. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 2 MAD phase MEDI7352 Dose 8 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 8 on Days 1, 15, 29, 43. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 2 MAD phase MEDI7352 Dose 4 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 4 on Days 1, 15, 29, 43. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 2 MAD phase MEDI7352 Dose 9 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 9 on Days 1, 15, 29, 43. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Experimental: Part 2 MAD phase MEDI7352 Dose 10 (IV) Participants in Part 2 of MAD phase will receive IV infusion of MEDI7352 Dose 10 on Days 1, 15, 29, 43. | Biological/Vaccine: MEDI7352 Participants will receive MEDI7352 IV/SC accordingly to the allocated arm. |
| Placebo Comparator: Part 2 MAD phase Placebo Participants in Part 2 of MAD phase will receive IV infusion of placebo matched to MEDI7352 on Days 1, 15, 29, 43. | Biological/Vaccine: Placebo Participants will receive placebo matched MEDI7352 IV/SC accordingly to the allocated arm. |
Contacts
Investigators
Principal Investigator
David Bell
Biokinetics
