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

Phase 2

Completed

• Conditions: Coronavirus Disease 2019 (COVID-19)
• Interventions: Drug: 600 mg AZD7442 IV; Drug: 600mg placebo IV

• Registration Number: NCT05184062
• Lead Sponsor: AstraZeneca

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-17
• Study Start: 2021-12-03
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2022-01-11
• Primary Completion: 2022-08-15
• Study Completion: 2023-05-06
• Results First Submitted: 2023-08-08
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Results First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

1. Adults ≥ 18 years
2. Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
3. Healthy or medically stable participants
4. Contraceptive within 365 days post dosing

Exclusion Criteria

1. Medical condition:

   • Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
   • Acute illness including fever on the day prior to or day of dosing.
   • Any other significant disease increase the risk to participant study.

2. Laboratory related:

   • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) > 1.5 × ULN, or TBL (total bilirubin) > 1.5 × ULN (unless due to Gilbert's syndrome).
   • Serum creatinine > 176 μmol/L.
   • Haemoglobin < 10g/dL.
   • Platelet count < 100 × 10^3/μL.
   • White blood cell count < 3.5 × 10^3/μL or neutrophil count < 1.5 × 10^3/μL.
   • Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.

3. COVID-19 infection history/any receipt of mAb indicated for COVID-19.

4. Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD7442	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.
Placebo	600mg placebo IV	co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Adverse Events of Special Interest	recorded from the time of signature of the ICF up to 245 days	Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.

Secondary Outcome Measures

Name	Time	Method
Serum Concentrations of AZD7442 Over Time	recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.	Serum concentrations for each scheduled time point are summarized based on the PK Analyses Set using descriptive statistics

Trial Locations

Locations (1)

Research Site; 🇨🇳 Xuzhou, China