Back to results

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

Primary Purpose

Coronavirus Disease 2019 (COVID-19), Healthy Volunteer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

AZD7442 IM

Placebo IM

AZD7442 IM

Placebo IM

AZD7442 IV

Placebo IV

AZD7442 IV

Placebo IV

About this trial

This is an interventional other trial for Coronavirus Disease 2019 (COVID-19) focused on measuring Coronavirus, COVID-19, AZD7442, Evusheld, LAAB, tixagevimab, AZD8895, cilgavimab, AZD1061

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

300 mg AZD7442 IM

300mg placebo IM

600 mg AZD7442 IM

600mg placebo IM

300 mg AZD7442 IV

300mg placebo IV

600 mg AZD7442 IV

600mg placebo IV

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Number of participants with abnormal laboratory test results

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

Number of participants with abnormal laboratory test results

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

Number of participants with abnormal Coagulation test results

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

Number of participants with abnormal urinalysis

Measurement of glucose, protein, and blood.

Number of participants with abnormal ECG readings

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

Number of participants with abnormal vital signs

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

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.

Number of participants with abnormal laboratory test results

Measurement of haemoglobin (Hb).

Number of participants with abnormal laboratory test results

Measurement of haematocrit (HCT).

Number of participants with abnormal laboratory test results

Measurement of mean corpuscular volume (MCV).

Number of participants with abnormal laboratory test results

Measurement of mean corpuscular haemoglobin (MCH).

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.

Number of participants with abnormal laboratory test results

Measurement of creatinine, total bilirubin, conjugated bilirubin.

Number of participants with abnormal laboratory test results

Measurement of albumin.

Number of participants with abnormal Coagulation test results

Measurement of international normalised ratio (INR).

Number of participants with abnormal ECG readings

Results for heart rate will be analyzed.

Number of participants with abnormal vital signs

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

Number of participants with abnormal vital signs

Measurement of body temperature (in degree Celsius).

Secondary Outcome Measures

Full Information

NCT ID

NCT05437289

First Posted

June 9, 2022

Last Updated

March 30, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT05437289

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 9, 2021 (Actual)

Primary Completion Date

November 27, 2021 (Actual)

Study Completion Date

January 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease 2019 (COVID-19), Healthy Volunteer

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

300 mg AZD7442 IM

Arm Type

Experimental

Arm Description

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

Arm Title

300mg placebo IM

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

600 mg AZD7442 IM

Arm Type

Experimental

Arm Description

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

Arm Title

600mg placebo IM

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

300 mg AZD7442 IV

Arm Type

Experimental

Arm Description

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

Arm Title

300mg placebo IV

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

600 mg AZD7442 IV

Arm Type

Experimental

Arm Description

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

Arm Title

600mg placebo IV

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AZD7442 IM

Other Intervention Name(s)

AZD7442

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo IM

Other Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

AZD7442 IM

Other Intervention Name(s)

AZD7442

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo IM

Other Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

AZD7442 IV

Other Intervention Name(s)

AZD7442

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo IV

Other Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AZD7442 IV

Other Intervention Name(s)

Evusheld

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo IV

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs)

Description

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

Time Frame