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

Boehringer Ingelheim

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 3810477

Study type: Interventional

Funder types: Industry

Identifiers

NCT06984926

2024-519327-20-00 (Registry Identifier)

1530-0002

U1111-1314-5841 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 5 patient groups, including a placebo group

BI 3810477_dose group 1

Experimental group

Treatment:

Drug: BI 3810477

BI 3810477_dose group 2

Experimental group

Treatment:

Drug: BI 3810477

BI 3810477_dose group 3

Experimental group

Treatment:

Drug: BI 3810477

BI 3810477_dose group 4

Experimental group

Treatment:

Drug: BI 3810477

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo