Healthy Adult ParticipantsPhase 1NCT07535775
Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers
A Phase 1 study testing BCD-261 in people with Healthy Adult Participants, run by SPH-BIOCAD (HK) Limited at 2 sites in China.
Trial summary
The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- BCD-261
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 11 May 2026to 20 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent to participate in the study.
- Male and female chinese subjects aged 18 to 45 years inclusively at the time of signing the ICF.
- The ability of the subject to follow the Protocol procedures, in the Investigator's opinion.
- A diagnosis of "healthy", established according to standard clinical, laboratory, and instrumental methods of examination carried out at screening, according to the assessment of the Investigator, as well as historical data (respiratory system, cardiovascular system, nervous systems, gastrointestinal tract system, urinary systems and etc.).
- Systolic blood pressure (SBP) ranging 90 to 139 mmHg, diastolic (DBP) ranging 50 to 89 mmHg, pulse ranging 50 to 100 bpm at screening.
- Willingness of the subjects and their female partners of childbearing potential to use reliable contraceptive methods from the moment of signing the ICF, throughout the whole study participation. This requirement does not apply to participants who have undergone surgical sterilization.
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- Willingness of subjects with reproductive potential to refrain from donating sperm/ oocytes, starting from the moment of signing the ICF, throughout the whole study participation. Females of childbearing potential must have a negative serum pregnancy test, be non-lactating, and have no plans to become pregnant during the study.
- Willingness to refrain from participating in any other clinical trials, starting from the moment of signing the ICF and throughout the whole study participation.
- Willingness to refrain from vaccination with any vaccines during the period from the moment of signing the ICF throughout the whole study participation.
- -
Who cannot join
- 1. Any medical or social condition that, in the opinion of the Investigator, prevents participation in this study.
- 2. Any confirmed or suspected immunosuppressive or immunodeficiency condition. 3. History of malignant disease. 4. Any acute infectious and non-infectious diseases, including the period of convalescence, within 4 weeks from the moment of clinical recovery to signing the ICF, as well as during screening.
- 5. Diagnosis of infectious mononucleosis (documented or reported by the subject) within 2 months before signing the ICF and during screening.
- 6. Vaccination with live vaccines within 8 weeks and with any other vaccines within 4 weeks prior to signing the ICF and during screening.
- 7. A history of allergies and signs of other significant adverse reactions after the administration of any medicinal products.
- 8. Hypersensitivity to the components of BCD-261. 9. Body mass index (BMI) outside the normal range (18.0 to 28.0 kg/m2). 10. Results of standard laboratory and instrumental tests (ECG, chest radiogrpahs) outside the normal ranges adopted at the study site and considered clinically significant by the investigator.
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- 11. Positive results of screening tests for HIV (anti-HIV antibodies and HIV antigen), hepatitis B (HBsAg, total anti-HBc, anti-HBs ) and C (anti-HCV antibodies) and/or syphilis antibody.
- 12. History of tuberculosis or current diagnosis of tuberculosis, or latent tuberculosis (positive IGRA).
- 13. Repeated positive urine drug test, repeated positive alcohol test at screening.
- 14. Difficulty with blood collection or intolerance to venipuncture (e.g., history of needle or blood phobia, skin disease at the puncture site).
- 15. Administration and use of the prohibited drugs. 16. Smoking of more than 10 cigarettes a day. 17. Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 20 mL of spirits) or a history of alcoholism, drug addiction or drug abuse.
- 18. Surgical interventions performed less than within 90 days before the signing of the ICF or planned surgery during the study period.
- 19. Donation of 450 mL or more of blood or plasma within 60 days prior to signing the ICF.
- 20. Participation in any clinical study of medicinal products and devices within 90 days before signing the ICF or previous participation in the current study with the exception of subjects who withdrew before the administration of the investigational product
Trial locations and contacts
2 sites in 1 country.
China2 sites
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: A Phase Ib, Open-Label Study Investigating the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers
The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers
- Conditions
- Healthy Adult Participants
- Being tested
- BCD-261
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-261Drug
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection.
| Study group | Role | What they receive |
|---|---|---|
| BCD-261 Dose Regimen A | Experimental | BCD-261 Dose Regimen A administered by subcutaneous injection Receives: Drug: BCD-261 |
| BCD-261 Dose Regimen B | Experimental | BCD-261 Dose Regimen B administered by subcutaneous injection Receives: Drug: BCD-261 |
| BCD-261 Dose Regimen C | Experimental | BCD-261 Dose Regimen C administered by subcutaneous injection Receives: Drug: BCD-261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects with serious adverse events
Measured: 309days
proportion of subjects with adverse events
Measured: 309days
proportion of subjects with CTCAE grade 3 or higher adverse events
Measured: 309days
proportion of subjects who prematurely withdrew from the study due to adverse events.
Measured: 309days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start11 May 2026
- Primary completion10 Oct 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPH-BIOCAD (HK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535775
- Sponsor's protocol ID
- BCD-261-3
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label Study Investigating the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT07535775
- Acronym / sponsor ID
- BCD-261-3
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- SPH-BIOCAD (HK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCD-261 Dose Regimen A | Experimental | Drug: BCD-261BCD-261 Dose Regimen A administered by subcutaneous injection |
| BCD-261 Dose Regimen B | Experimental | Drug: BCD-261BCD-261 Dose Regimen B administered by subcutaneous injection |
| BCD-261 Dose Regimen C | Experimental | Drug: BCD-261BCD-261 Dose Regimen C administered by subcutaneous injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent to participate in the study.
- Male and female chinese subjects aged 18 to 45 years inclusively at the time of signing the ICF.
- The ability of the subject to follow the Protocol procedures, in the Investigator's opinion.
- A diagnosis of "healthy", established according to standard clinical, laboratory, and instrumental methods of examination carried out at screening, according to the assessment of the Investigator, as well as historical data (respiratory system, cardiovascular system, nervous systems, gastrointestinal tract system, urinary systems and etc.).
- Systolic blood pressure (SBP) ranging 90 to 139 mmHg, diastolic (DBP) ranging 50 to 89 mmHg, pulse ranging 50 to 100 bpm at screening.
Key exclusion criteria (14 listed)
- 1. Any medical or social condition that, in the opinion of the Investigator, prevents participation in this study.
- 2. Any confirmed or suspected immunosuppressive or immunodeficiency condition. 3. History of malignant disease. 4. Any acute infectious and non-infectious diseases, including the period of convalescence, within 4 weeks from the moment of clinical recovery to signing the ICF, as well as during screening.
- 5. Diagnosis of infectious mononucleosis (documented or reported by the subject) within 2 months before signing the ICF and during screening.
- 6. Vaccination with live vaccines within 8 weeks and with any other vaccines within 4 weeks prior to signing the ICF and during screening.
- 7. A history of allergies and signs of other significant adverse reactions after the administration of any medicinal products.
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 |
|---|---|---|
| BCD-261Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection. | Drug | BCD-261 Dose Regimen A, BCD-261 Dose Regimen B, BCD-261 Dose Regimen C |
Primary outcome
proportion of subjects with serious adverse events
Time frame: 309days
proportion of subjects with adverse events
Time frame: 309days
proportion of subjects with CTCAE grade 3 or higher adverse events
Time frame: 309days
proportion of subjects who prematurely withdrew from the study due to adverse events.
Time frame: 309days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCD-261 in people with Healthy Adult Participants, run by SPH-BIOCAD (HK) Limited at 2 sites 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
proportion of subjects with serious adverse events (time frame: 309days). The study lists 4 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 26 Jun 2026.