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Completed

NCT Number: NCT04691180

A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigative Site

Beijing, Beijing Municipality, 100015, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 19.0-26.0kg/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

Treatment and study plan

BRII-196 and BRII-198

Drug

BRII-196 and BRII-198 given intravenously

Placebo

Drug

Placebo given intravenously

Primary outcomes

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

    Time frame: up to 24 weeks

  2. Proportion of subjects with SAEs

    Time frame: up to 24 weeks

Secondary outcomes

  1. Proportion of subjects with infusion-related reactions

    Time frame: up to 24 weeks

  2. Proportion of subjects with hypersensitivity reactions

    Time frame: up to 24 weeks

  3. Mean of change from pre-dose baseline in ECG readings

    Time frame: up to 24 weeks

    ECG readings include PR interval, RR interval, QRS interval, etc.

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

    Time frame: up to 24 weeks

  5. Mean of change from pre-dose baseline in RBC count

    Time frame: up to 24 weeks

  6. Mean of change from pre-dose baseline in Platelets count

    Time frame: up to 24 weeks

  7. Mean of change from pre-dose baseline in Hemoglobin result

    Time frame: up to 24 weeks

  8. Serum Concentration of BRII-196 and BRII-198

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Brii Biosciences Limited

Industry

Collaborators

  • TSB Therapeutics (Beijing) CO.LTD

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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