Study identifier:D5290C00007
ClinicalTrials.gov identifier:NCT04840849
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Evaluate PK profile
Phase 1
Yes
-
All
24
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Dec 2022 by AstraZeneca
AstraZeneca
IQVIA RDS (Shanghai) Co., Ltd.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Nirsevimab Nirsevimab single dose IM injection | Biological/Vaccine: nirsevimab Drug: injection, a single fixed IM dose on day 1 only. Other Name: MEDI8897 |
Placebo Comparator: Placebo Placebo single dose IM injection | Other: Placebo Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only. |