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

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 3810477 in Healthy Male and Female Trial Participants (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06984926

Enrollment

Registered

2025-05-22

Start date

2025-06-06

Completion date

2026-03-09

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBI 3810477

BI 3810477

DRUGPlacebo

Placebo for BI 3810477

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* 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. * Further inclusion criteria apply.

Exclusion criteria

* 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. * Further

Design outcomes

Primary

Measure	Time frame
Occurrence of any treatment-emergent adverse events assessed as drug-related by the investigator	Up to Day 117

Secondary

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026