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

Study 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

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 09 Oct 2021

Primary Completion Date: 27 Nov 2021

Study Completion Date: 16 Jan 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Nov 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Shanghai, China, 201107

Location

Research Site

Guangzhou, China, 510515

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

Documents available

D8850C00007 Clinical Study Report synopsis Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

A study to evaluate the safety and tolerability of AZD7442 in Healthy Chinese Adults

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Documents available

D8850C00007 Clinical Study Report synopsis Redacted

Trial Results Summaries

Contacts

Contact