Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198
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ClinicalTrials.gov Identifier: NCT04479644 |
Recruitment Status :
Completed
First Posted : July 21, 2020
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: BRII-198 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibody, BRII-198 Administered Intravenously to Healthy Adult Volunteers |
Actual Study Start Date : | July 13, 2020 |
Actual Primary Completion Date : | February 3, 2021 |
Actual Study Completion Date : | February 3, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
BRII-198 dose level 1 or placebo
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Drug: BRII-198
BRII-198 given intravenously Drug: Placebo Placebo given intravenously |
Experimental: Cohort 2
BRII-198 dose level 2 or placebo
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Drug: BRII-198
BRII-198 given intravenously Drug: Placebo Placebo given intravenously |
Experimental: Cohort 3
BRII-198 dose level 3 or placebo
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Drug: BRII-198
BRII-198 given intravenously Drug: Placebo Placebo given intravenously |
- Incidence of adverse events (AEs) by CTCAE v5.0 [ Time Frame: up to 24 weeks ]
- Proportion of subjects with SAEs [ Time Frame: up to 24 weeks ]
- Proportion of subjects with infusion-related reactions [ Time Frame: up to 24 weeks ]
- Proportion of subjects with hypersensitivity reactions [ Time Frame: up to 24 weeks ]
- Serum Concentration of BRII-198 [ Time Frame: up to 24 weeks ]

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479644
China, Beijing | |
Investigative Site | |
Beijing, Beijing, China |
Study Director: | Yao Zhang | TSB Therapeutics (Beijing) CO.LTD |
Responsible Party: | Brii Biosciences Limited |
ClinicalTrials.gov Identifier: | NCT04479644 |
Other Study ID Numbers: |
BRII-198-001 |
First Posted: | July 21, 2020 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 phase I monoclonal antibody |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |