NCT06745297 A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
| NCT ID | NCT06745297 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2027-02-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 172 participants in total. It began in 2025-01-23 with a primary completion date of 2027-02-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
Eligibility Criteria
Inclusion criteria: 1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory. 2. Age of 18 to 50 years (inclusive) 3. BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Exclusion criteria: 1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements. 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06745297 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06745297 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06745297 currently recruiting?
Yes, NCT06745297 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT06745297 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT06745297 clinical trial?
NCT06745297 is sponsored by Boehringer Ingelheim. The trial plans to enroll 172 participants.