NCT05985200

Brief Summary

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)).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2023

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

August 3, 2023

Last Update Submit

November 19, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Occurrence of any treatment-emergent adverse event

    Up to Day 137

Secondary Outcomes (3)

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

    Up to Day 137

  • Area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ (AUCτ,)

    From Day 22 to Day 134

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

    From Day 22 to Day 134

Study Arms (5)

BI 3032950: Dose group 1

EXPERIMENTAL
Drug: BI 3032950

BI 3032950: Dose group 2

EXPERIMENTAL
Drug: BI 3032950

BI 3032950: Dose group 3

EXPERIMENTAL
Drug: BI 3032950

BI 3032950: Dose group 4

EXPERIMENTAL
Drug: BI 3032950

Placebo

PLACEBO COMPARATOR
Drug: Placebo matching BI 3032950

Interventions

BI 3032950DRUG

BI 3032950

BI 3032950: Dose group 1BI 3032950: Dose group 2BI 3032950: Dose group 3BI 3032950: Dose group 4
Placebo matching BI 3032950DRUG

Placebo matching BI 3032950

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Age of 18 to 65 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
  • 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
  • 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.
  • Postmenopausal or surgically sterilised female subjects (WNOCBP) who are:
  • Confirmed surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or

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 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
  • 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)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

Study Design

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

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

September 15, 2023

Primary Completion

August 19, 2024

Study Completion

August 19, 2024

Last Updated

November 21, 2024

Record last verified: 2024-11

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.mystudywindow.com/msw/datatransparency.

Locations

BE(1)