BI 3006337
DrugBI 3006337
NCT Number: NCT05076422
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
SGS Life Science Services - Clinical Research, Edegem, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BI 3006337
Placebo
Time frame: From 1 day pre-dose till end of trial, up to 40 days
Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞).
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Maximum measured concentration of BI 3006337 in serum (Cmax) is reported.
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported.
Boehringer Ingelheim
Industry
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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