Study identifier:D8850C00001
ClinicalTrials.gov identifier:NCT04507256
EudraCT identifier:2020-003076-40
CTIS identifier:N/A
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults
COVID-19
Phase 1
Yes
AZD7442
All
60
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
Parexel International
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD7442 Participants will receive AZD7442 doses across five fixed-dose cohorts via intravenous (IV) infusions (three cohorts will be administered sequentially, and one cohort will receive co-administration of AZD8895 + AZD1061, mixed into a single infusion) and direct gluteal intramuscular (IM) injections (administered sequentially). | Combination Product: AZD7442 Participants randomized to AZD7442 will be administered dose 1, each in Cohort 1a (IM) and Cohort 1b (IV). Participants in Cohort 2 and 3 will receive AZD7442 (IV) doses 2 and 3, respectively. Participants in Cohort 4 will receive AZD7442 (IV) dose 4. |
Placebo Comparator: Placebo Placebo will be administered to participants across five fixed-dose cohorts similar to the active treatment. | Other: Placebo Participants randomised to placebo will receive the same volume of solution as participants on active treatment. |