Actively Recruiting
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
Led by Biocad · Updated on 2024-12-16
48
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses to healthy male subjects aged from 18 to 45 years old. The study consists of the first stage (dose escalation) and the second stage (dose expansion).
CONDITIONS
Official Title
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study.
- Male subjects aged 18 to 45 years at the time of signing the informed consent form.
- Ability to follow the study procedures as judged by the investigator.
- Healthy status confirmed by clinical, laboratory, and instrumental examinations, with no acute or chronic diseases.
- Normal systolic blood pressure (100-130 mmHg), diastolic blood pressure (60-90 mmHg), and pulse rate (60-90 bpm) at screening.
- Willingness to use reliable contraception from signing the informed consent until Day 57, unless surgically sterile.
- Willingness to avoid donating sperm from signing the informed consent until Day 57.
- Willingness to avoid participation in other clinical trials during the study.
- Willingness to avoid vaccination from signing the informed consent until Day 127.
You will not qualify if you...
- Any medical or social condition preventing participation as judged by the investigator.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition.
- Acute infectious or non-infectious diseases, including recovery periods, within 4 weeks prior to screening.
- Diagnosis of infectious mononucleosis within 2 months before screening.
- Vaccination with live vaccines within 8 weeks or any vaccines within 4 weeks prior to screening.
- History of allergies or significant adverse reactions to any medications.
- Hypersensitivity to components of BCD-261.
- Body mass index outside 18.0 to 30.0 kg/m2 range.
- Abnormal laboratory or instrumental test results.
- Positive tests for HIV, hepatitis B, hepatitis C, or tuberculosis.
- Repeated positive urine drug or saliva alcohol tests at screening.
- Inability to perform venipuncture due to skin conditions.
- Use of any medications regularly within 14 days prior to study start.
- Prior use of anti-TL1A monoclonal antibodies.
- Use of drugs affecting hemodynamics or liver function within 30 days prior to study start.
- Use of drugs affecting immune status within 60 days prior to study start.
- Smoking more than 10 cigarettes daily.
- Consuming more than 10 units of alcohol weekly or history of substance abuse.
- Surgical interventions within 90 days prior to informed consent.
- Blood or plasma donation of 450 mL or more within 60 days prior to informed consent.
- Participation in any clinical drug study within 90 days prior to informed consent or prior participation in this study except those who withdrew before dosing.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
"Meditsinskiy teсhnologiy Maly"
Saint Petersburg, Russia, 197198
Actively Recruiting
Research Team
Y
Yulia E Tsarikhina, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
10
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