A Study in Healthy People to Test How Well Repeated Doses of BI 3032950 Are Tolerated

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 3032950; Drug: Placebo matching BI 3032950

Study type: Interventional

Funder types: Industry

Identifiers

NCT05985200

2023-503332-40-00 (Registry Identifier)

U1111-1289-1904 (Registry Identifier)

1486-0002

Details and patient eligibility

About

The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising intravenous doses of BI 3032950 in healthy male subjects and postmenopausal or surgically sterilised female subjects (women not of child bearing potential (WNOCBP)).

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects and female subjects not of child bearing potential (women not of child bearing potential (WNOCBP)) - postmenopausal or surgically sterilised female 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)), 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 29.9 kg/m^2 (inclusive)

4. Signed and dated written informed consent in accordance with International conference on harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

5. Male subjects (including male subjects with pregnant partners) who meet any of the criteria listed in the protocol for a highly effective contraception from the first administration of trial medication until the end of study (EoS) visit.

6. Postmenopausal or surgically sterilised female subjects (WNOCBP) who are:

   • Confirmed surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or
   • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without an alternative medical cause 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 blood pressure outside the range of 90 to 140 millimetre 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); in case of documented 'white coat hypertension' the decision for eligibility is left to the investigator
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. 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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40 participants in 5 patient groups, including a placebo group

BI 3032950: Dose group 1

Experimental group

Treatment:

Drug: BI 3032950

BI 3032950: Dose group 2

Experimental group

Treatment:

Drug: BI 3032950

BI 3032950: Dose group 3

Experimental group

Treatment:

Drug: BI 3032950

BI 3032950: Dose group 4

Experimental group

Treatment:

Drug: BI 3032950

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3032950