SARS-CoV-2 InfectionPhase 1NCT05518695
Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects
A Phase 1 study testing BAT2022 in people with SARS-CoV-2 Infection, run by Bio-Thera Solutions at 1 site in China.
Trial summary
To evaluate the safety and tolerability of BAT2022 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- BAT2022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2022to 7 Nov 2022
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Subjects who have smoked more than 5 cigarettes per day three months prior to Screening;
- Any subject with a current or past serious allergic reaction to food or drug, or serious allergic or allergic reaction to human, humanized or mouse monoclonal antibody;
- Subjects with a history of alcoholism (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 125 mL of wine);
- Subjects who have donated blood or had massive blood loss (>450 mL) within three months prior to screening, or intend to donate blood or undergo surgery during the study;
- Subjects who have taken any prescription drug, over-the-counter drug, any vitamin products or herbal medicines 28 days prior to Screening;
- Subjects who have significant changes in diet or exercise habits 2 weeks prior to screening or from screening to administration;
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- Subjects who have used any biological products within 3 months prior to screening;
- Subjects with clinical significance of abnormal heart assessed using Color Doppler echocardiography
- Subjects with clinical significance of abnormal laboratory findings (hematology, urinalysis, serum chemistry, coagulation function, virology of infectious diseases and pregnancy test for women of childbearing age), or other clinical findings suggestive of the following disorders with clinical relevance (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases);
- Subjects with clinical significance of abnormal (as judged by the investigator) ECG, or QTcF > 450 ms (allowed to be repeated for once);
- Subjects with acute illness or concomitant medication from screening to prior to administration of the investigational product;
- Subjects with positive urine drug screen, or subjects with a history of drug abuse or drug use in the past 5 years;
- Subjects who have taken any alcohol-containing products within 48 hours prior to administration of the investigational product, or who are unable to limit alcohol consumption as required during the course of the study;
- Subjects with current or previous malignant tumours;
- Subjects with a history of hypertension or systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg at screening/baseline;
- Subjects with liver disorder who are judged by the investigator as inappropriate for enrollment;
- Subjects with abnormal focal shadows on chest radiograph, including but not limited to active pulmonary tuberculosis;
- Subjects who have participated in drug clinical study within three months prior to the first dose of the investigational product, or planned to participate in other drug clinical study during the study;
- Subjects who are considered by the investigator as inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital Tong Ji Medical College University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Randomized, Double-Blind, Phase I Clinical Study to Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects
To evaluate the safety and tolerability of BAT2022 in healthy subjects.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- BAT2022
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT2022Drug
Also called BAT2022 for Injection (bispecific neutralizing antibody targeting the receptor binding domain (RBD) of spike of SARS-CoV-2)
Eight healthy subjects are planned to be enrolled in each group, 6 on the investigational product and 2 on placebo. Subjects will be randomized (3:1) to receive a single intravenous injection of BAT2022 for Injection or 5% glucose injection. Sentinel dosing will be performed for subjects in each group.Two subjects in each group who have received the first dose will be randomized (1:1) to either the test group or placebo group. After observation for 24 h and the drug is safe and well tolerated, the remaining subjects in this group will be randomized (5:1) to either the test group or placebo group.
| Study group | Role | What they receive |
|---|---|---|
| A1/100mg | Experimental | Drug:BAT2022 for Intravenous fluids 100mg Receives: Drug: BAT2022 |
| A2/300mg | Experimental | Drug:BAT2022 for Intravenous fluids 300mg Receives: Drug: BAT2022 |
| A3/1000mg | Experimental | Drug:BAT2022 for Intravenous fluids 1000mg Receives: Drug: BAT2022 |
| A4/1500mg | Experimental | Drug:BAT2022 for Intravenous fluids 1500mg Receives: Drug: BAT2022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Grade ≥3 AEs in this criteria are defined as dose-limiting toxicity (DLT).
Measured: DLT observation period is 7 days postdose.
Secondary outcomes (1)
Maximum tolerated dose (MTD)
it is determined that ≥ 50% of subjects have experienced a DLT as defined in this protocol
Measured: DLT observation period is 7 days postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start9 Jun 2022
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiyong Li, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518695
- Sponsor's protocol ID
- BAT-2022-001-CR
- Status last verified
- Nov 2022
- First submitted
- 25 Aug 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase I Clinical Study to Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05518695
- Acronym / sponsor ID
- BAT-2022-001-CR
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 29 Aug 2022 (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.
To evaluate the safety and tolerability of BAT2022 in healthy subjects.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1/100mg | Experimental | Drug: BAT2022Drug:BAT2022 for Intravenous fluids 100mg |
| A2/300mg | Experimental | Drug: BAT2022Drug:BAT2022 for Intravenous fluids 300mg |
| A3/1000mg | Experimental | Drug: BAT2022Drug:BAT2022 for Intravenous fluids 1000mg |
| A4/1500mg | Experimental | Drug: BAT2022Drug:BAT2022 for Intravenous fluids 1500mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Subjects who have smoked more than 5 cigarettes per day three months prior to Screening;
- Any subject with a current or past serious allergic reaction to food or drug, or serious allergic or allergic reaction to human, humanized or mouse monoclonal antibody;
- Subjects with a history of alcoholism (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 125 mL of wine);
- Subjects who have donated blood or had massive blood loss (>450 mL) within three months prior to screening, or intend to donate blood or undergo surgery during the study;
- Subjects who have taken any prescription drug, over-the-counter drug, any vitamin products or herbal medicines 28 days prior to Screening;
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 |
|---|---|---|
| BAT2022Also: BAT2022 for Injection (bispecific neutralizing antibody targeting the receptor binding domain (RBD) of spike of SARS-CoV-2)Eight healthy subjects are planned to be enrolled in each group, 6 on the investigational product and 2 on placebo. Subjects will be randomized (3:1) to receive a single intravenous injection of BAT2022 for Injection or 5% glucose injection. Sentinel dosing will be performed for subjects in each group.Two subjects in each group who have received the first dose will be randomized (1:1) to either the test group or placebo group. After observation for 24 h and the drug is safe and well tolerated, the remaining subjects in this group will be randomized (5:1) to either the test group or placebo group. | Drug | A1/100mg, A2/300mg, A3/1000mg, A4/1500mg |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: DLT observation period is 7 days postdose.
Grade ≥3 AEs in this criteria are defined as dose-limiting toxicity (DLT).
1 secondary outcome
Maximum tolerated dose (MTD)
Time frame: DLT observation period is 7 days postdose.
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 15 Nov 2022.
- 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.
Weiyong Li principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 BAT2022 in people with SARS-CoV-2 Infection, run by Bio-Thera Solutions 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 0 inclusion and 19 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 15 Nov 2022. 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?
Dose limiting toxicity (DLT) (time frame: DLT observation period is 7 days postdose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2022.