A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People

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

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female subjects following administration of single rising doses and administration of multiple rising doses.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 3804379; Drug: Placebo matching BI 3804379

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • SGS Life Science Services - Clinical Research
    • Contact: Boehringer Ingelheim; Phone Number: 080049616; Email: belgique@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRD Part: BI 3804379; SRD= Single rising dose	Drug: BI 3804379; BI 3804379
Placebo Comparator: SRD Part: Placebo matching BI 3804379	Drug: Placebo matching BI 3804379; Placebo matching BI 3804379
Experimental: MRD Part: BI 3804379; MRD=Multiple rising dose.	Drug: BI 3804379; BI 3804379
Placebo Comparator: MRD Part: Placebo matching BI 3804379	Drug: Placebo matching BI 3804379; Placebo matching BI 3804379

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SRD part and MRD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator	Up to Day 84 for SRD part and up to Day 235 for MRD part.

Secondary Outcome Measures

Outcome Measure	Time Frame
SRD part: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	Up to Day 84.
SRD part: Cmax (maximum measured concentration of the analyte in plasma)	Up to Day 84.
MRD part: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to Day 235.
MRD part: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to Day 235.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): March 20, 2028

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1524-0001; 2024-513549-36-00 (Registry Identifier: CTIS); U1111-1306-8874 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No