Clinical trial NCT04691180: A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
Official title: A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19 phase I
monoclonal antibody
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: TSB Therapeutics (Beijing) CO.LTD
First posted: 2020-12-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

1. Subject must be 18 to 49 years of age inclusive
2. Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-26.0kg/m2 (inclusive).
3. Male or female

Exclusion Criteria:

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation.
2. A history of significant hypersensitivity, intolerance, or allergy to any drug compound
3. History of alcohol or other substance abuse

Primary outcomes:
measure: Incidence of adverse events (AEs) by CTCAE v5.0
timeFrame: up to 24 weeks
measure: Proportion of subjects with SAEs
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Proportion of subjects with infusion-related reactions
timeFrame: up to 24 weeks
measure: Proportion of subjects with hypersensitivity reactions
timeFrame: up to 24 weeks
measure: Mean of change from pre-dose baseline in ECG readings
timeFrame: up to 24 weeks
measure: Mean of change from pre-dose baseline in WBC count.
timeFrame: up to 24 weeks
measure: Mean of change from pre-dose baseline in RBC count
timeFrame: up to 24 weeks
measure: Mean of change from pre-dose baseline in Platelets count
timeFrame: up to 24 weeks
measure: Mean of change from pre-dose baseline in Hemoglobin result
timeFrame: up to 24 weeks
measure: Serum Concentration of BRII-196 and BRII-198
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigative Site
state: Beijing
Study officials:
affiliation: TSB Therapeutics (Beijing) CO.LTD
name: Yao Zhang
role: STUDY_DIRECTOR
References:
citation: Hao X, Zhang Z, Ma J, Cheng L, Ji Y, Liu Y, Zhao D, Zhang W, Li C, Yan L, Margolis D, Zhu Q, Zhang Y, Zhang F. Randomized, placebo-controlled, single-blind phase 1 studies of the safety, tolerability, and pharmacokinetics of BRII-196 and BRII-198, SARS-CoV-2 spike-targeting monoclonal antibodies with an extended half-life in healthy adults. Front Pharmacol. 2022 Sep 6;13:983505. doi: 10.3389/fphar.2022.983505. eCollection 2022.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.