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 IM, Placebo IM, AZD7442 IV, Placebo IV, 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 |
