A Study to Test How Well Multiple Doses of BI 3810477 Are Tolerated by Healthy Adults

NCT06984926 | Completed Phase 1

• 3 other identifiers: 1530-00022024-519327-20-00U1111-1314-5841
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 3810477 in healthy male and female trial participants when given as multiple rising doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Occurrence of any treatment-emergent adverse events assessed as drug-related by the investigator

  Up to Day 117

Secondary Outcomes (2)

• Area under the concentration-time curve of BI 3810477 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

  Up to Day 117

• Maximum measured concentration of BI 3810477 in plasma at steady state (Cmax,ss)

  Up to Day 117

Study Arms (5)

BI 3810477_dose group 1

EXPERIMENTAL

Drug: BI 3810477

BI 3810477_dose group 2

EXPERIMENTAL

Drug: BI 3810477

BI 3810477_dose group 3

EXPERIMENTAL

Drug: BI 3810477

BI 3810477_dose group 4

EXPERIMENTAL

Drug: BI 3810477

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 3810477 DRUG

BI 3810477

BI 3810477_dose group 1; BI 3810477_dose group 2; BI 3810477_dose group 3; BI 3810477_dose group 4

Placebo DRUG

Placebo for BI 3810477

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female participants 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), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
• Age of 18 to 60 years (inclusive, to be checked at time of signing informed consent).
• BMI of 18.5 to 29.9 kg/m2 (inclusive).
• Signed and dated written informed consent in accordance with international conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.

You may not qualify if:

• Any finding in the medical examination (including BP, PR, RR, temperature or 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats per minute (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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 22, 2025
• Study Start: June 6, 2025
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)