NCT07526194

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 in healthy male trial participants.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
5mo left

Started Apr 2026

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

April 22, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

March 31, 2026

Last Update Submit

April 10, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    Up to 60 days

Secondary Outcomes (3)

  • Area under the concentration-time curve of the analyte in blood over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Up to 60 days

  • Maximum measured concentration of the analyte in blood (Cmax)

    Up to 60 days

  • Percentage of participants treated with investigational drug who experience a treatment-emergent adverse event

    Up to 60 days

Study Arms (10)

Dose group 1

EXPERIMENTAL

part A

Drug: BI 3821001

Dose group 2

EXPERIMENTAL

part A

Drug: BI 3821001

Dose group 3

EXPERIMENTAL

part A

Drug: BI 3821001

Dose group 4

EXPERIMENTAL

part A

Drug: BI 3821001

Dose group 5

EXPERIMENTAL

part A

Drug: BI 3821001

Dose group 6

EXPERIMENTAL

part A

Drug: BI 3821001

Dose group 7

EXPERIMENTAL

part B

Drug: BI 3821001

Dose group 8

EXPERIMENTAL

part B

Drug: BI 3821001

Dose group 9

EXPERIMENTAL

part B

Drug: BI 3821001

Placebo group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BI 3821001DRUG

BI 3821001

Dose group 1Dose group 2Dose group 3Dose group 4Dose group 5Dose group 6Dose group 7Dose group 8Dose group 9
PlaceboDRUG

Placebo

Placebo group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male trial participant 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 55 years (inclusive)
  • Body mass idnex (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

You may not qualify if:

  • Any finding in the medical examination (including BP, PR 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

Related Links

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Study Design

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

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 13, 2026

Study Start (Estimated)

April 22, 2026

Primary Completion (Estimated)

October 2, 2026

Study Completion (Estimated)

October 2, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Locations

DE(1)