NCT04691180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

December 17, 2020

Last Update Submit

March 2, 2023

Conditions

COVID-19

Keywords

COVID-19 phase Imonoclonal antibody

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events (AEs) by CTCAE v5.0

    up to 24 weeks

  • Proportion of subjects with SAEs

    up to 24 weeks

Secondary Outcomes (8)

  • Proportion of subjects with infusion-related reactions

    up to 24 weeks

  • Proportion of subjects with hypersensitivity reactions

    up to 24 weeks

  • Mean of change from pre-dose baseline in ECG readings

    up to 24 weeks

  • Mean of change from pre-dose baseline in WBC count.

    up to 24 weeks

  • Mean of change from pre-dose baseline in RBC count

    up to 24 weeks

  • +3 more secondary outcomes

Study Arms (2)

Cohort 1

EXPERIMENTAL

BRII-196 and BRII-198 dose level 1 or placebo

Drug: BRII-196 and BRII-198Drug: Placebo

Cohort 2

EXPERIMENTAL

BRII-196 and BRII-198 dose level 2 or placebo

Drug: BRII-196 and BRII-198Drug: Placebo

Interventions

BRII-196 and BRII-198DRUG

BRII-196 and BRII-198 given intravenously

Cohort 1Cohort 2
PlaceboDRUG

Placebo given intravenously

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigative Site

Beijing, Beijing Municipality, 100015, China

Location

Related Publications (2)

  • 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.

    PMID: 36147329DERIVED

  • 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.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

amubarvimabromlusevimab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yao Zhang

    TSB Therapeutics (Beijing) CO.LTD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 31, 2020

Study Start

January 5, 2021

Primary Completion

September 16, 2021

Study Completion

September 16, 2021

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)