Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single S… (NCT07535775) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers
China48 participantsStarted 2026-05-11
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
proportion of subjects with serious adverse events
Timeframe: 309days
2
proportion of subjects with adverse events
Timeframe: 309days
3
proportion of subjects with CTCAE grade 3 or higher adverse events
Timeframe: 309days
4
proportion of subjects who prematurely withdrew from the study due to adverse events.