A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in Healthy Chinese Adults
Overview
- Phase
- Phase 1
- Intervention
- AZD7442 IM
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Sponsor
- AstraZeneca
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Number of participants with abnormal Coagulation test results
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: AZD7442 IM
300mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
Intervention: Placebo IM
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.
Intervention: AZD7442 IM
600mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
Intervention: Placebo IM
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.
Intervention: AZD7442 IV
300mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
Intervention: Placebo IV
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.
Intervention: AZD7442 IV
600mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
Intervention: Placebo IV
Outcomes
Primary Outcomes
Number of participants with abnormal Coagulation test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of international normalised ratio (INR).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of albumin.
Incidence of adverse events (AEs)
Time Frame: 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)
Time Frame: 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 urinalysis
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of glucose, protein, and blood.
Incidence of adverse event of special interests (AESIs)
Time Frame: 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 ECG readings
Time Frame: 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
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of body temperature (in degree Celsius).