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

Sponsor

AstraZeneca (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05437289

Collaborator

(none)

Enrollment

Locations

Arms

16.1

Anticipated Duration (Months)

30.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease 2019 (COVID-19) Healthy Volunteer	Drug: AZD7442 IM Drug: Placebo IM Drug: AZD7442 IM Drug: Placebo IM Drug: AZD7442 IV Drug: Placebo IV Drug: AZD7442 IV Drug: Placebo IV	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 9, 2021

Actual Primary Completion Date :

Nov 27, 2021

Anticipated Study Completion Date :

Feb 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 300 mg AZD7442 IM Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.	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. Other Names: AZD7442
Placebo Comparator: 300mg placebo IM Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.	Drug: 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. Other Names: Placebo
Experimental: 600 mg AZD7442 IM Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.	Drug: 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. Other Names: AZD7442
Placebo Comparator: 600mg placebo IM Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.	Drug: 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. Other Names: Placebo
Experimental: 300 mg AZD7442 IV co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.	Drug: 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. Other Names: AZD7442
Placebo Comparator: 300mg placebo IV co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.	Drug: 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. Other Names: Placebo
Experimental: 600 mg AZD7442 IV co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.	Drug: 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. Other Names: Evusheld
Placebo Comparator: 600mg placebo IV co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.	Drug: 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. Other Names: Placebo

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.