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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Coronavirus Disease 2019 (COVID-19); Healthy Volunteer

Treatments: Drug: AZD7442 IM; Drug: Placebo IM; Drug: Placebo IV; Drug: AZD7442 IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT05437289

D8850C00007

Details and patient eligibility

About

To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo

Full description

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV) infusion, and approximately 479 days in duration for each participant.

Enrollment: 61 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adults 18 to 55 years of age
2. Healthy by medical history, physical examination, and baseline safety laboratory tests
3. Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
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) > upper limit of normal (ULN), or alkaline phosphatase (ALP) or TBL (total bilirubin) > 1.5 × ULN
   • Serum creatinine > ULN
   • Haemoglobin < lower limit normal (LLN)
   • Platelet count < LLN
   • White blood cell or neutrophil count outside normal reference ranges
   • 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 8 patient groups, including a placebo group

300 mg AZD7442 IM

Experimental group

Description:

Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.

Treatment:

Drug: AZD7442 IM

300mg placebo IM

Placebo Comparator group

Description:

Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.

Treatment:

Drug: Placebo IM

600 mg AZD7442 IM

Experimental group

Description:

Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.

Treatment:

Drug: AZD7442 IM

600mg placebo IM

Placebo Comparator group

Description:

Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.

Treatment:

Drug: Placebo IM

300 mg AZD7442 IV

Experimental group

Description:

co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.

Treatment:

Drug: AZD7442 IV

Drug: AZD7442 IV

300mg placebo IV

Placebo Comparator group

Description:

co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.

Treatment:

Drug: Placebo IV

600 mg AZD7442 IV

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: AZD7442 IV

Drug: AZD7442 IV

600mg placebo IV

Placebo Comparator group

Description:

co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.

Treatment:

Drug: Placebo IV