Tolerability of different doses of BI 3821001 in healthy men

A Phase I Single-blind, Randomised, Placebo-controlled, Parallel Group Design Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 3821001 Administered to Healthy Trial Participants

This trial will test how safe and tolerable different doses of the experimental drug BI 3821001 are in healthy men aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Berlin)
• Trial ID: NCT07526194 on ClinicalTrials.gov

What this trial studies

This phase 1 interventional trial enrolls healthy male volunteers to receive one or more doses of BI 3821001 or placebo and monitors them closely for safety, tolerability, and pharmacokinetics. Participants undergo regular vital sign checks, ECGs, laboratory testing, and blood sampling for drug concentration measurements. The trial is conducted at a clinical research site in Berlin under sponsor oversight to define dose-related effects and inform dosing for later studies. Eligibility requires a normal medical assessment including labs, ECG, and blood pressure within specified ranges.

Who should consider this trial

Good fit: Ideal candidates are healthy men aged 18–55 with a BMI of 18.5–29.9 kg/m2 who have normal labs, ECG, and vital signs and can provide informed consent.

Not a fit: People with existing health problems, abnormal laboratory values or ECG, blood pressure or pulse outside the required ranges, women, or those outside the specified age or BMI ranges are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify safe dose ranges and dosing schedules for BI 3821001 to guide later clinical development.

How similar studies have performed: This is a standard early-phase tolerability and pharmacokinetic approach commonly used in drug development, and similar first-in-human or phase 1 trials have routinely informed safe dosing for later studies.

Eligibility criteria

Inclusion Criteria:

1. Healthy male 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
2. Age of 18 to 55 years (inclusive)
3. Body mass idnex (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply

Where this trial is running

Berlin

• CRS Clinical Research Services Berlin GmbH — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy