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

Primary Purpose

Coronavirus Disease 2019 (COVID-19)

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

600 mg AZD7442 IV

600mg placebo IV

About this trial

This is an interventional other trial for Coronavirus Disease 2019 (COVID-19) focused on measuring Coronavirus, COVID-19, AZD7442

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults ≥ 18 years
Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
Healthy or medically stable participants
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) > 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) > 1.5 × ULN, or TBL (total bilirubin) > 1.5 × ULN (unless due to Gilbert's syndrome).
- Serum creatinine > 176 μmol/L.
- Haemoglobin < 10g/dL.
- Platelet count < 100 × 10^3/μL.
- White blood cell count < 3.5 × 10^3/μL or neutrophil count < 1.5 × 10^3/μL.
- 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.
COVID-19 infection history/any receipt of mAb indicated for COVID-19.
Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AZD7442

Placebo

Arm Description

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 600mg placebo by intravenous (IV) infusion.

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs)

To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age.

Incidence of serious adverse events (SAEs)

To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age.

Incidence of adverse event of special interests (AESIs)

To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age.

Safety as determined by abnormality in haematology

Measurement of white blood cell (WBC) count, red blood cell (RBC) count, haemoglobin (Hb), haematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count.

Safety as determined by abnormality in clinical chemistry

Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), creatinine, albumin, calcium, phosphate, glucose, c-reactive protein (CRP), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), total bilirubin, conjugated bilirubin, creatine kinase.

Safety as determined by abnormality in urinalysis

Measurement of glucose, protein, blood and microscopy.

Safety as determined by abnormality in Coagulation.

Measurement of international normalised ratio (INR), prothrombin time, activated partial thrombin time (aPTT).

Incidence of abnormal 12-lead electrocardiogram (ECG)

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

Safety as determined by abnormal vital signs (blood pressure, pulse rate, body temperature, and respiratory rate)

Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg), pulse rate (beats per minute), body temperature (in degree Celsius), respiratory rate (breaths per minute).

Secondary Outcome Measures

Full Information

NCT ID

NCT05184062

First Posted

November 17, 2021

Last Updated

May 17, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT05184062

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

December 3, 2021 (Actual)

Primary Completion Date

August 15, 2022 (Actual)

Study Completion Date

May 6, 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 and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).

Detailed Description

A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), 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)

Keywords

Coronavirus, COVID-19, AZD7442

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

272 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AZD7442

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

Placebo

Arm Type

Placebo Comparator

Arm Description

co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.

Intervention Type

Drug

Intervention Name(s)

600 mg AZD7442 IV

Other Intervention Name(s)

AZD7442

Intervention Description

Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.

Intervention Type

Drug

Intervention Name(s)

600mg placebo IV

Other Intervention Name(s)

Placebo

Intervention Description

Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs)

Description

To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age.

Time Frame