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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-1904 | Registry Identifier | WHO Registry | |
| 2023-503332-40-00 | Registry Identifier | CTIS (EU) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 3032950: Dose group 1 | Experimental |
| |
| BI 3032950: Dose group 2 | Experimental |
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| BI 3032950: Dose group 3 | Experimental |
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| BI 3032950: Dose group 4 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3032950 | Drug | BI 3032950 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any treatment-emergent adverse event | Up to Day 137 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Ï„ (AUCÏ„,) | From Day 22 to Day 134 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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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:
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| Placebo matching BI 3032950 | Drug | Placebo matching BI 3032950 |
|
| Maximum measured concentration of the analyte in serum (Cmax) | From Day 22 to Day 134 |