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

Phase 1

Completed

• Conditions: Healthy Volunteer; Coronavirus Disease 2019 (COVID-19)
• Interventions: Drug: AZD7442 IM; Drug: AZD7442 IV; Drug: Placebo IM; Drug: Placebo IV

• Registration Number: NCT05437289
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-10-09
• Primary Completion: 2021-11-27
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Study Completion: 2023-01-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
600 mg AZD7442 IM	AZD7442 IM	Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
300 mg AZD7442 IV	AZD7442 IV	co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV	AZD7442 IV	co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
600mg placebo IM	Placebo IM	Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
300mg placebo IV	Placebo IV	co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
600mg placebo IV	Placebo IV	co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
300 mg AZD7442 IM	AZD7442 IM	Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
300mg placebo IM	Placebo IM	Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal Coagulation test results	From day 1 to approximately 15 months after administration (through Day 451).	Measurement of international normalised ratio (INR).
Number of participants with abnormal laboratory test results	From day 1 to approximately 15 months after administration (through Day 451).	Measurement of albumin.
Incidence of adverse events (AEs)	From day 1 to approximately 15 months after administration (through Day 451).	To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Incidence of serious adverse events (SAEs)	From day 1 to approximately 15 months after administration (through Day 451).	To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Number of participants with abnormal urinalysis	From day 1 to approximately 15 months after administration (through Day 451).	Measurement of glucose, protein, and blood.
Incidence of adverse event of special interests (AESIs)	From day 1 to approximately 15 months after administration (through Day 451).	To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Number of participants with abnormal ECG readings	From day 1 to approximately 15 months after administration (through Day 451).	Results for heart rate will be analyzed.
Number of participants with abnormal vital signs	From day 1 to approximately 15 months after administration (through Day 451).	Measurement of body temperature (in degree Celsius).

Trial Locations

Locations (1)

Research Site; 🇨🇳 Shanghai, China