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

NCT05437289 | Completed Phase 1 DMC

• 1 other identifier: D8850C00007
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Coronavirus Disease 2019 (COVID-19); Healthy Volunteer

Keywords

Coronavirus; COVID-19; AZD7442; Evusheld; LAAB; tixagevimab; AZD8895; cilgavimab; AZD1061

Outcome Measures

Primary Outcomes (21)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• Number of participants with abnormal urinalysis

  Measurement of glucose, protein, and blood.

  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.

  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).

  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.

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

• Number of participants with abnormal laboratory test results

  Measurement of haemoglobin (Hb).

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

• Number of participants with abnormal laboratory test results

  Measurement of haematocrit (HCT).

  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).

  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).

  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.

  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.

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

• Number of participants with abnormal laboratory test results

  Measurement of albumin.

  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).

  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.

  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).

  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).

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

Study Arms (8)

300 mg AZD7442 IM

EXPERIMENTAL

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

Drug: AZD7442 IM

300mg placebo IM

PLACEBO COMPARATOR

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

Drug: Placebo IM

600 mg AZD7442 IM

EXPERIMENTAL

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

Drug: AZD7442 IM

600mg placebo IM

PLACEBO COMPARATOR

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

Drug: Placebo IM

300 mg AZD7442 IV

EXPERIMENTAL

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

Drug: AZD7442 IV

300mg placebo IV

PLACEBO COMPARATOR

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

Drug: Placebo IV

600 mg AZD7442 IV

EXPERIMENTAL

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

Drug: AZD7442 IV

600mg placebo IV

PLACEBO COMPARATOR

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

Drug: Placebo IV

Interventions

AZD7442 IM DRUG

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.

Also known as: AZD7442

300 mg AZD7442 IM

Placebo IM DRUG

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.

Also known as: Placebo

300mg placebo IM

AZD7442 IV DRUG

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.

Also known as: AZD7442

300 mg AZD7442 IV

Placebo IV DRUG

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

Also known as: Placebo

300mg placebo IV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18 to 55 years of age
• Healthy by medical history, physical examination, and baseline safety laboratory tests
• Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
• Contraceptive within 365 days post dosing

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Guangzhou, 510515, China

Location

Research Site

Shanghai, 201107, China

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

cilgavimab and tixagevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 29, 2022
• Study Start: October 9, 2021
• Primary Completion: November 27, 2021
• Study Completion: January 16, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (2)