A study to evaluate the safety and tolerability of AZD7442 in Healthy Chinese Adults
Study identifier:D8850C00007
ClinicalTrials.gov identifier:NCT05437289
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in Healthy Chinese Adults
Medical condition
Coronavirus disease 2019 (COVID-19), Healthy Volunteer
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD7442 IM, Placebo IM, AZD7442 IV, Placebo IV
Sex
All
Actual Enrollment
61
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 09 Oct 2021
Primary Completion Date: 27 Nov 2021
Estimated Study Completion Date: 10 Feb 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verification:
Verified 01 Nov 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 300 mg AZD7442 IM Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection. | Drug: AZD7442 IM In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections. Other Name: AZD7442 |
| Placebo Comparator: 300mg placebo IM Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. | Drug: Placebo IM In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. Other Name: Placebo |
| Experimental: 600 mg AZD7442 IM Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection. | Drug: AZD7442 IM In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections. Other Name: AZD7442 |
| Placebo Comparator: 600mg placebo IM Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. | Drug: Placebo IM In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. Other Name: Placebo |
| Experimental: 300 mg AZD7442 IV co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion. | Drug: AZD7442 IV In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. Other Name: AZD7442 |
| Placebo Comparator: 300mg placebo IV co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. | Drug: Placebo IV In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. Other Name: Placebo |
| Experimental: 600 mg AZD7442 IV co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. | Drug: AZD7442 IV In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. Other Name: Evusheld |
| Placebo Comparator: 600mg placebo IV co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. | Drug: Placebo IV In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. Other Name: Placebo |
