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

Healthy Volunteer Clinical Trial

Official title:

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in Healthy Chinese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05437289
• Other study ID #: D8850C00007
• Status: Completed
• Phase: Phase 1
• Start date: October 9, 2021
• Est. completion date: January 16, 2023

Study information

• Verified date: March 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 16, 2023
• Est. primary completion date: November 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019 (COVID-19)
• Coronavirus Infections
• COVID-19
• Healthy Volunteer

Intervention

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

Locations

Country	Name	City	State
China	Research Site	Guangzhou
China	Research Site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	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.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	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.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of white blood cell (WBC) count, red blood cell (RBC) count.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), calcium, phosphate, glucose, c-reactive protein (CRP).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal Coagulation test results	Measurement of prothrombin time, activated partial thrombin time (aPTT).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal urinalysis	Measurement of glucose, protein, and blood.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal ECG readings	Results for PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal vital signs	Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	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.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of haemoglobin (Hb).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of haematocrit (HCT).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of mean corpuscular volume (MCV).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of mean corpuscular haemoglobin (MCH).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	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.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of creatinine, total bilirubin, conjugated bilirubin.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal laboratory test results	Measurement of albumin.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal Coagulation test results	Measurement of international normalised ratio (INR).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal ECG readings	Results for heart rate will be analyzed.	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal vital signs	Measurement of pulse rate (beats per minute), respiratory rate (breaths per minute).	From day 1 to approximately 15 months after administration (through Day 451).
Primary	Number of participants with abnormal vital signs	Measurement of body temperature (in degree Celsius).	From day 1 to approximately 15 months after administration (through Day 451).