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

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-08-19

Brief Summary

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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)).

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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 3032950: Dose group 1

Group Type EXPERIMENTAL

BI 3032950

Intervention Type DRUG

BI 3032950

BI 3032950: Dose group 2

Group Type EXPERIMENTAL

BI 3032950

Intervention Type DRUG

BI 3032950

BI 3032950: Dose group 3

Group Type EXPERIMENTAL

BI 3032950

Intervention Type DRUG

BI 3032950

BI 3032950: Dose group 4

Group Type EXPERIMENTAL

BI 3032950

Intervention Type DRUG

BI 3032950

Placebo

Group Type PLACEBO_COMPARATOR

Placebo matching BI 3032950

Intervention Type DRUG

Placebo matching BI 3032950

Interventions

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BI 3032950

Intervention Type DRUG

Placebo matching BI 3032950

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes