Coronavirus Disease 2019 (COVID-19), Healthy Volunteer
Conditions
Keywords
Coronavirus, COVID-19, AZD7442, Evusheld, LAAB, tixagevimab, AZD8895, cilgavimab, AZD1061
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.
Interventions
DRUGAZD7442 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.
DRUGPlacebo 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.
DRUGAZD7442 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.
DRUGPlacebo 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.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
Countries
China
Outcome results
None listed