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

NCT ID: NCT06984926

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-06

Study Completion Date

2026-03-09

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BI 3810477_dose group 1

Group Type EXPERIMENTAL

BI 3810477

Intervention Type DRUG

BI 3810477

BI 3810477_dose group 2

Group Type EXPERIMENTAL

BI 3810477

Intervention Type DRUG

BI 3810477

BI 3810477_dose group 3

Group Type EXPERIMENTAL

BI 3810477

Intervention Type DRUG

BI 3810477

BI 3810477_dose group 4

Group Type EXPERIMENTAL

BI 3810477

Intervention Type DRUG

BI 3810477

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for BI 3810477

Interventions

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BI 3810477

BI 3810477

Intervention Type DRUG

Placebo

Placebo for BI 3810477

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SGS Life Science Services - Clinical Research

Edegem, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2024-519327-20-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1314-5841

Identifier Type: REGISTRY

Identifier Source: secondary_id

1530-0002

Identifier Type: -

Identifier Source: org_study_id