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

AstraZeneca61 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Coronavirus Disease 2019 (COVID-19)Healthy Volunteer

Interventions

AZD7442 IMDRUG

In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections.

Placebo IMDRUG

In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.

AZD7442 IMDRUG

In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Research Site

Guangzhou, China

Research Site

Shanghai, China

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Incidence of serious adverse events (SAEs)

To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Incidence of adverse event of special interests (AESIs)

To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of white blood cell (WBC) count, red blood cell (RBC) count.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), calcium, phosphate, glucose, c-reactive protein (CRP).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal Coagulation test results

Measurement of prothrombin time, activated partial thrombin time (aPTT).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal urinalysis

Data from ClinicalTrials.gov

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In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.

AZD7442 IVDRUG

In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.

Placebo IVDRUG

In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.

AZD7442 IVDRUG

In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.

Placebo IVDRUG

In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.

Measurement of glucose, protein, and blood.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal ECG readings

Results for PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal vital signs

Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of haemoglobin (Hb).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of haematocrit (HCT).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of mean corpuscular volume (MCV).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of mean corpuscular haemoglobin (MCH).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), creatine kinase.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of creatinine, total bilirubin, conjugated bilirubin.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal laboratory test results

Measurement of albumin.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal Coagulation test results

Measurement of international normalised ratio (INR).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal ECG readings

Results for heart rate will be analyzed.

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal vital signs

Measurement of pulse rate (beats per minute), respiratory rate (breaths per minute).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).

Number of participants with abnormal vital signs

Measurement of body temperature (in degree Celsius).

Time frame: From day 1 to approximately 15 months after administration (through Day 451).