Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198
- Registration Number
- NCT04479644
- Lead Sponsor
- Brii Biosciences Limited
- Brief Summary
This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- Subject must be 18 to 49 years of age inclusive;
- Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive);
- Male or female;
Exclusion Criteria
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
- A history of significant hypersensitivity, intolerance, or allergy to any drug compound;
- History of alcohol or other substance abuse;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 BRII-198 BRII-198 dose level 1 or placebo Cohort 1 Placebo BRII-198 dose level 1 or placebo Cohort 2 BRII-198 BRII-198 dose level 2 or placebo Cohort 2 Placebo BRII-198 dose level 2 or placebo Cohort 3 Placebo BRII-198 dose level 3 or placebo Cohort 3 BRII-198 BRII-198 dose level 3 or placebo
- Primary Outcome Measures
Name Time Method Proportion of subjects with infusion-related reactions up to 24 weeks Incidence of adverse events (AEs) by CTCAE v5.0 up to 24 weeks Proportion of subjects with SAEs up to 24 weeks Proportion of subjects with hypersensitivity reactions up to 24 weeks
- Secondary Outcome Measures
Name Time Method Serum Concentration of BRII-198 up to 24 weeks
Trial Locations
- Locations (1)
Investigative Site
🇨🇳Beijing, Beijing, China