COVID-19Phase 1NCT04691180
A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
A Phase 1 study testing BRII-196 and BRII-198 in people with COVID-19, run by Brii Biosciences Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- BRII-196 and BRII-198
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2021to 16 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- BRII-196 and BRII-198, Placebo
- Keywords
- COVID-19 phase I, monoclonal antibody
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRII-196 and BRII-198Drug
BRII-196 and BRII-198 given intravenously
PlaceboDrug
Placebo given intravenously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BRII-196 and BRII-198 dose level 1 or placebo Receives: Drug: BRII-196 and BRII-198; Drug: Placebo |
| Cohort 2 | Experimental | BRII-196 and BRII-198 dose level 2 or placebo Receives: Drug: BRII-196 and BRII-198; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) by CTCAE v5.0
Measured: up to 24 weeks
Proportion of subjects with SAEs
Measured: up to 24 weeks
Secondary outcomes (8)
Proportion of subjects with infusion-related reactions
Measured: up to 24 weeks
Proportion of subjects with hypersensitivity reactions
Measured: up to 24 weeks
Mean of change from pre-dose baseline in ECG readings
ECG readings include PR interval, RR interval, QRS interval, etc.
Measured: up to 24 weeks
Mean of change from pre-dose baseline in WBC count.
Measured: up to 24 weeks
Mean of change from pre-dose baseline in RBC count
Measured: up to 24 weeks
Mean of change from pre-dose baseline in Platelets count
Measured: up to 24 weeks
Mean of change from pre-dose baseline in Hemoglobin result
Measured: up to 24 weeks
Serum Concentration of BRII-196 and BRII-198
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start5 Jan 2021
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brii Biosciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TSB Therapeutics (Beijing) CO.LTD
- Responsible party
- Sponsor
- Investigators
- Yao Zhang, Study director, TSB Therapeutics (Beijing) CO.LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691180
- Sponsor's protocol ID
- BRII-196-198-001
- Status last verified
- Mar 2023
- First submitted
- 17 Dec 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36147329Kreuzberger 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.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04691180
- Acronym / sponsor ID
- BRII-196-198-001
- Conditions
- COVID-19
- Keywords
- COVID-19 phase I, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Brii Biosciences LimitedIndustry (pharma, biotech, devices)
- Collaborators
- TSB Therapeutics (Beijing) CO.LTD
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BRII-196 and BRII-198, Drug: PlaceboBRII-196 and BRII-198 dose level 1 or placebo |
| Cohort 2 | Experimental | Drug: BRII-196 and BRII-198, Drug: PlaceboBRII-196 and BRII-198 dose level 2 or placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRII-196 and BRII-198BRII-196 and BRII-198 given intravenously | Drug | Cohort 1, Cohort 2 |
| PlaceboPlacebo given intravenously | Drug | Cohort 1, Cohort 2 |
Primary outcome
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
8 secondary outcomes
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
Mean of change from pre-dose baseline in ECG readings
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in WBC count.
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in RBC count
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in Platelets count
Time frame: up to 24 weeks
Mean of change from pre-dose baseline in Hemoglobin result
Time frame: up to 24 weeks
Serum Concentration of BRII-196 and BRII-198
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 36147329Hao 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.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Zhang study director
TSB Therapeutics (Beijing) CO.LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BRII-196 and BRII-198 in people with COVID-19, run by Brii Biosciences Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) by CTCAE v5.0 (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691180, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.