Testing the safety and tolerability of BI 3804379 in healthy individuals

A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Rising Subcutaneous Doses of BI 3804379 in Healthy Male and Female Subjects

This study is testing a new drug called BI 3804379 in healthy men and women to see if it's safe and how well their bodies handle it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Edegem)
• Trial ID: NCT06575400 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the safety, tolerability, and pharmacokinetics of BI 3804379 in healthy male and female participants. It involves administering single and multiple rising doses of the drug to assess how well it is tolerated. Participants will undergo thorough medical assessments to ensure they meet health criteria before enrollment. The study is designed to gather important data on the drug's effects in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18.5 and 30.0.

Not a fit: Patients with significant health issues or abnormal medical examination findings may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety profile of BI 3804379, paving the way for its use in future treatments.

How similar studies have performed: Other studies have shown success in evaluating the safety and tolerability of new drugs in healthy populations, making this approach well-established.

Eligibility criteria

Inclusion criteria:

1. Healthy male or female (of non-child-bearing potential) subjects 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), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 65 years (inclusive)
3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (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 BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.

Further exclusion criteria apply.

Where this trial is running

Edegem

• SGS Life Science Services - Clinical Research — Edegem, Belgium (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy