NCT07908004 A Study to Test How Well Different Doses of BI 3821001 Are Tolerated by Healthy People
| NCT ID | NCT07908004 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-11-03 |
| Primary Completion | 2027-06-22 |
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 40 participants in total. It began in 2026-11-03 with a primary completion date of 2027-06-22.
⚠ 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 main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 administrations of multiple rising doses.
Eligibility Criteria
Inclusion Criteria: * Healthy male or female of non-childbearing potential trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure \[BP\], pulse rate \[PR\]), 12-lead electrocardiogram (ECG), and clinical laboratory tests * Aged 18 to 55 years (inclusive) * Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) * Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply. Exclusion Criteria: * 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 * Repeated measurement 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 bpm * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * 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 NCT07908004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 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 NCT07908004 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 NCT07908004 currently recruiting?
Yes, NCT07908004 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT07908004 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07908004 clinical trial?
NCT07908004 is sponsored by Boehringer Ingelheim. The trial plans to enroll 40 participants.