Coronavirus Disease 2019Early Phase 1NCT05369754
A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, PK and Immunogenicity of YBSW015 in Healthy Subjects
A Early Phase 1 study testing YBSW015 injection in people with Coronavirus Disease 2019, run by Yabao Pharmaceutical Group.
Trial summary
This is phase Ia study to research YBSW015 injection which is a monomolecular bispecific antibody. The Primary objective is to evaluate the safety and tolerability of YBSW015 injection after a single intravenous injection at different doses in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- YBSW015 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Feb 2023
- Phase
- Early 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged ≥ 18 years and ≤ 55 years at screening, regardless of gender;
- Body weight ≥50kg for males and ≥45kg for females, body mass index (BMI) between 18.0 kg/m2and 30.0 kg/m2 (inclusive) at screening;
- Subject who has negative result in the YBSW015 serology test in screening;
- Has completed COVID-19 vaccination and the last dose more than 6 weeks prior to randomization
- Subject who are normal in the physical examination, vital signs, laboratory tests and other auxiliary examinations (chest radiograph, abdominal ultrasound scan, 12-lead ECG, etc.), or abnormal without clinical significance as judged by the investigator;
- Subject who has a negative result in the urine human chorionic gonadotropin test in screening period, and a negative result in the blood human chorionic gonadotropin test in baseline period;
- Subjects (including their partners) who do not have a pregnancy plan and are willing to adopt effective contraception measures from signing the informed consent to 6 months after administration of the investigational drug;
- Subjects who has understood the trial feature, significance, possible benefits, possible inconveniences and potential risks and discomforts in detail, and are willing to participate in this clinical trial and are able to communicate well with the investigator and follow the requirements of the entire study, and has signed the written informed consent form prior to the trial.
Who cannot join
- The positive results are obtained in SARS-CoV-2 nucleic acid test using nasal swabs prior to screening and randomization (results within 7 days prior to randomization);
- Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization；
- Those who have received any SARS-CoV-2 immunoglobulin, plasma from COVID-19 survivors in recovery period（within 15 weeks）;
- Those who have used therapeutic biologics within 12 weeks before screening, or those who are in drug elimination period currently (within 5 half-lives), whichever is longer;
- Those who have participated in clinical study of other intervention investigational products within 12 weeks prior to screening, or those who are in drug elimination period currently (within 5 half-lives), whichever is longer;
- Those who have been vaccinated against pathogens other than SARS CoV-2 within 6 weeks prior to screening, or plan to be vaccinated against pathogens other than SARS CoV-2 during the study or within 6 weeks after the study;
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- Those who have taken herbal medicines, dietary supplements (excluding vitamin, mineral and trace element supplements), or any prescription or non-prescription drugs within 14 days (inclusive) prior to screening;
- Those who have had major surgery history within 8 weeks (including 8 weeks) before screening, or plan to perform surgeries during the study, and those who are exposed to unacceptable risks brought by such surgery at the discretion of the sponsor and the investigator;
- Those who have an abnormal electrocardiogram with clinical significance at screening, or QTc> 450 msec, or other abnormal electrocardiogram data with clinical significance;
- Subjects with poor blood pressure control (systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg);
- Positive serology test results for hepatitis C virus antibody, human immunodeficiency virus antibody, Syphilis Treponema Pallidum antibody (S-TP) and hepatitis B virus surface antigen (HBsAg) at Screening;
- Those who have a history of transplantation in vital organs (such as heart, lung, liver and kidney);
- Patients with malignant tumors (excluding those whose malignant tumors have been cured with no recurrence in recent 5 years, with complete excision of skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of any type);
- Those who have cardiovascular diseases, respiratory diseases, gastrointestinal diseases, endocrine system diseases, hematological system diseases or nervous system diseases, and are exposed to higher risks by taking the investigational drug, or those whose disease state can obviously change absorption, distribution, metabolism or excretion of the investigational drug;
- Those who have a history of drug abuse or drug taking within 5 years prior to screening or have a positive result in urine drug test;
- Those who have a history of alcoholism or excessive drinking (14 units of alcohol per week :1 unit = 285 mL beer, or 25 mL liquor, or 100 mL wine) within 6 months prior to screening or have a positive result in alcohol breath test;
- Those who smoke ≥5 cigarettes per day within 6 months prior to screening, or are unwilling/unable to stop nicotine intake during the study;
- Those who are known to be allergic to the investigational drug, monoclonal antibody drug, therapeutic protein preparation, human serum albumin, cytokines, interleukin etc. or have a history of or a propensity to allergy;
- Females with a positive result of pregnancy test and lactating females;
- Those who have a blood loss or donation of greater than 400 mL, or received blood transfusion or blood products within the past 3 months, or plan to donate blood during the study;
- Those with a history of needle sickness, hemophobia or intolerance of venipunctures;
- Subjects who cannot complete the study due to other reasons or are supposed to be excluded at the discretion of the investigator.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of YBSW015 Injection in Healthy Subjects
This is phase Ia study to research YBSW015 injection which is a monomolecular bispecific antibody. The Primary objective is to evaluate the safety and tolerability of YBSW015 injection after a single intravenous injection at different doses in healthy subjects.
The Secondary objective is to evaluate the pharmacokinetic characteristics and immunogenicity of different doses of YBSW015 injection after a single intravenous injection in healthy subjects. This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation clinical trial.
- Conditions
- Coronavirus Disease 2019
- Being tested
- YBSW015 injection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YBSW015 injectionBiological
Prepared YBSW015 injection is intravenously injected by an infusion pump or gravity infusion with intravenous infusion of 250 mL for 60 min±10 min.
| Study group | Role | What they receive |
|---|---|---|
| YBSW015 injection 180mg | Experimental | Not described Receives: Biological: YBSW015 injection |
| YBSW015 injection 450mg | Experimental | Not described Receives: Biological: YBSW015 injection |
| YBSW015 injection 900mg | Experimental | Not described Receives: Biological: YBSW015 injection |
| YBSW015 injection 1800mg | Experimental | Not described Receives: Biological: YBSW015 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of YBSW015 injection
Evaluation of treatment-emergent adverse event (TEAE) and serious adverse events (SAE) during treatment;
Measured: from screening visit to the end of the follow-up period, assessed up to 85 days
tolerability of YBSW015 injection
Evaluation of local tolerance: administration site reaction;
Measured: from screening visit to the end of the follow-up period, assessed up to 85 days
Secondary outcomes (12)
PK parameter
Peak concentration (Cmax) Immunogenicity: To detect the positive rate and titer of anti-drug antibody ADA
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
peak time (Tmax)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
terminal elimination rate constant (λz)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
terminal elimination half-life (t1/2)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
area under the curve from time zero to the time of the last time of quantifiable concentration (AUC0-t)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
area under the concentration-time curve from time zero to infinite time (AUC0-∞)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
extrapolated percentage of AUC0-∞ (%AUCex)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
apparent clearance (CLz)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
apparent volume of distribution (Vz)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
mean residence time (MRT)
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
Immunogenicity
positive rate of anti-drug antibody ADA
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
Immunogenicity
Titer of anti-drug antibody ADA
Measured: from screening visit to the end of follow-up period, assessed up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study startJul 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yabao Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369754
- Sponsor's protocol ID
- YBSW015001
- Status last verified
- Apr 2022
- First submitted
- 30 Apr 2022
- Last updated
- 11 May 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of YBSW015 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05369754
- Acronym / sponsor ID
- YBSW015001
- Conditions
- Coronavirus Disease 2019
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yabao Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 11 May 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.
This is phase Ia study to research YBSW015 injection which is a monomolecular bispecific antibody. The Primary objective is to evaluate the safety and tolerability of YBSW015 injection after a single intravenous injection at different doses in healthy subjects.
The Secondary objective is to evaluate the pharmacokinetic characteristics and immunogenicity of different doses of YBSW015 injection after a single intravenous injection in healthy subjects. This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YBSW015 injection 180mg | Experimental | Biological: YBSW015 injection |
| YBSW015 injection 450mg | Experimental | Biological: YBSW015 injection |
| YBSW015 injection 900mg | Experimental | Biological: YBSW015 injection |
| YBSW015 injection 1800mg | Experimental | Biological: YBSW015 injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years and ≤ 55 years at screening, regardless of gender;
- Body weight ≥50kg for males and ≥45kg for females, body mass index (BMI) between 18.0 kg/m2and 30.0 kg/m2 (inclusive) at screening;
- Subject who has negative result in the YBSW015 serology test in screening;
- Has completed COVID-19 vaccination and the last dose more than 6 weeks prior to randomization
- Subject who are normal in the physical examination, vital signs, laboratory tests and other auxiliary examinations (chest radiograph, abdominal ultrasound scan, 12-lead ECG, etc.), or abnormal without clinical significance as judged by the investigator;
Key exclusion criteria (22 listed)
- The positive results are obtained in SARS-CoV-2 nucleic acid test using nasal swabs prior to screening and randomization (results within 7 days prior to randomization);
- Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization；
- Those who have received any SARS-CoV-2 immunoglobulin, plasma from COVID-19 survivors in recovery period（within 15 weeks）;
- Those who have used therapeutic biologics within 12 weeks before screening, or those who are in drug elimination period currently (within 5 half-lives), whichever is longer;
- Those who have participated in clinical study of other intervention investigational products within 12 weeks prior to screening, or those who are in drug elimination period currently (within 5 half-lives), whichever is longer;
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 |
|---|---|---|
| YBSW015 injectionPrepared YBSW015 injection is intravenously injected by an infusion pump or gravity infusion with intravenous infusion of 250 mL for 60 min±10 min. | Biological | YBSW015 injection 1800mg, YBSW015 injection 180mg, YBSW015 injection 450mg, YBSW015 injection 900mg |
Primary outcome
safety of YBSW015 injection
Time frame: from screening visit to the end of the follow-up period, assessed up to 85 days
Evaluation of treatment-emergent adverse event (TEAE) and serious adverse events (SAE) during treatment;
tolerability of YBSW015 injection
Time frame: from screening visit to the end of the follow-up period, assessed up to 85 days
Evaluation of local tolerance: administration site reaction;
12 secondary outcomes
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
Immunogenicity
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
Immunogenicity
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing YBSW015 injection in people with Coronavirus Disease 2019, run by Yabao Pharmaceutical Group.
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 8 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
safety of YBSW015 injection (time frame: from screening visit to the end of the follow-up period, assessed up to 85 days). 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?
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 11 May 2022.