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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Coronavirus Disease 2019 (COVID-19)

Treatments: Drug: 600 mg AZD7442 IV; Drug: 600mg placebo IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT05184062

D8850C00008

Details and patient eligibility

About

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).

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

272 participants in 2 patient groups, including a placebo group

AZD7442

Experimental group

Description:

co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.

Treatment:

Drug: 600 mg AZD7442 IV

Placebo

Placebo Comparator group

Description:

co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.

Treatment:

Drug: 600mg placebo IV