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

Coronavirus Disease 2019 (COVID-19) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184062
• Other study ID #: D8850C00008
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2021
• Est. completion date: May 6, 2023

Study information

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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: May 6, 2023
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults = 18 years

2. Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)

3. Healthy or medically stable participants

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) > 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.

3. COVID-19 infection history/any receipt of mAb indicated for COVID-19.

4. Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Research Site	Baoding
China	Research Site	Beijing
China	Research Site	Changsha
China	Research Site	Chongqing
China	Research Site	Fuzhou
China	Research Site	Haikou
China	Research Site	Hangzhou
China	Research Site	Lanzhou
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Suzhou
China	Research Site	Urumqi
China	Research Site	Xuzhou

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 a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) = 18 years of age.	From day1 to 6 months after administration.
Primary	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.	From day1 to 6 months after administration.
Primary	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.	From day1 to 6 months after administration.
Primary	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.	From day1 to 6 months after administration.
Primary	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.	From day1 to 6 months after administration.
Primary	Safety as determined by abnormality in urinalysis	Measurement of glucose, protein, blood and microscopy.	From day1 to 6 months after administration.
Primary	Safety as determined by abnormality in Coagulation.	Measurement of international normalised ratio (INR), prothrombin time, activated partial thrombin time (aPTT).	From day1 to 6 months after administration.
Primary	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.	From day1 to 6 months after administration.
Primary	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).	From day1 to 6 months after administration.