Clinical trial NCT05437289: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronavirus Disease 2019 (COVID-19)
Healthy Volunteer
Keywords: Coronavirus
COVID-19
AZD7442
Evusheld
LAAB
tixagevimab
AZD8895
cilgavimab
AZD1061
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Adults 18 to 55 years of age
2. Healthy by medical history, physical examination, and baseline safety laboratory tests
3. Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
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) \> 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.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Incidence of serious adverse events (SAEs)
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Incidence of adverse event of special interests (AESIs)
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal Coagulation test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal urinalysis
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal ECG readings
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal vital signs
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal laboratory test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal Coagulation test results
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal ECG readings
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal vital signs
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
measure: Number of participants with abnormal vital signs
timeFrame: From day 1 to approximately 15 months after administration (through Day 451).
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
Study officials:
References: