NCT05184062

A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults

A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).

Detailed description

A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.

Conditions

• Coronavirus Disease 2019 (COVID-19)

Interventions

Type	Name	Description
DRUG	600 mg AZD7442 IV	Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.
DRUG	600mg placebo IV	Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.

Timeline

• Start date: 2021-12-03
• Primary completion: 2022-08-15
• Completion: 2023-05-06
• First posted: 2022-01-11
• Last updated: 2024-11-21
• Results posted: 2024-11-21

Locations

14 sites across 1 country: China