Phase 1 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing and able to sign a consent form agreeing to take part in the study.
• You are a male between 18 and 45 years old (for certain groups in the trial, you must also be of Asian background — confirm with trial site).
• In the opinion of the study doctor, you are able to follow the study procedures and requirements.
• You have been assessed as healthy, with no current or ongoing conditions affecting the lungs, heart, nervous system, digestive system, liver, or kidneys.
• Your blood pressure and heart rate are within a normal range (blood pressure between 100–130/60–90 mmHg, pulse between 60–90 beats per minute).
• You and your female partner (if she can become pregnant) are willing to use reliable contraception from signing consent through to Day 57 of the study, unless you have had a surgical procedure that prevents you from fathering children.
• You are willing to avoid donating sperm from the time you sign the consent form until Day 57 of the study.
• You are willing not to take part in any other clinical trials for the entire duration of this study.
• You are willing to avoid receiving any vaccines from the time you sign the consent form until Day 127 of the study.

Who may not be able to join:

• You have any medical or personal circumstances that, in the study doctor's opinion, make participation unsuitable.
• You have, or are suspected to have, a condition that weakens or suppresses your immune system.
• You have had any illness (infectious or otherwise) within the 4 weeks before signing the consent form, or you are currently unwell.
• You have been diagnosed with glandular fever (infectious mononucleosis) within the 2 months before signing the consent form, or are currently diagnosed with it.
• You have received a live vaccine in the past 8 weeks, or any other type of vaccine in the past 4 weeks.
• You have a history of allergic reactions or other significant reactions to any medicines.
• You have a known sensitivity or allergy to the ingredients of the study drug (BCD-261).
• Your body mass index (BMI) is below 18.0 or above 30.0 kg/m².
• Your routine blood or other test results at screening fall outside the normal ranges used at the study site.
• You test positive for HIV, hepatitis B, hepatitis C, or tuberculosis at screening.
• You test positive more than once for drugs in your urine or alcohol in your saliva during screening.
• It is not possible to take blood from a vein (for example, due to a skin condition at the needle site).
• You have taken any regular prescribed or over-the-counter medicines, vitamins, or supplements within 14 days before the planned start of the study.
• You have ever previously used a type of medication known as an anti-TL1A monoclonal antibody (confirm with trial site).
• You have taken any medicines known to significantly affect blood pressure or liver function (such as certain stomach medications) within 30 days before the planned start of the study.
• You have taken any medicines that affect the immune system (such as steroids or certain other treatments) within 60 days before the planned start of the study.
• You smoke more than 10 cigarettes per day.
• You drink more than 10 units of alcohol per week, or you have a history of alcohol or drug dependency or misuse.
• You have had surgery within the 90 days before signing the consent form.
• You have donated 450 mL or more of blood or plasma within the 60 days before signing the consent form.
• You have taken part in another clinical drug trial within the 90 days before signing the consent form, or you previously took part in this same trial and received the study drug.

Important: Always verify eligibility with the trial site directly before applying.