Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337Primary· 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.
Group
Value
95% CI
Placebo
0
BI 3006337 0.2 mg
0
BI 3006337 0.5 mg
1
BI 3006337 1 mg
0
BI 3006337 2 mg
0
BI 3006337 4 mg
2
BI 3006337 8 mg
0
BI 3006337 15 mg
0
BI 3006337 30 mg
0
BI 3006337 50 mg
2
BI 3006337 100 mg
1
BI 3006337 150 mg
1
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)Secondary· 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-∞).
Group
Value
95% CI
BI 3006337 0.2 mg
NA
± NA
BI 3006337 0.5 mg
NA
± NA
BI 3006337 1 mg
534
± 20.7
BI 3006337 2 mg
1200
± 52.8
BI 3006337 4 mg
2870
± 32.5
BI 3006337 8 mg
3190
± 44.9
BI 3006337 15 mg
7920
± 26.5
BI 3006337 30 mg
15100
± 38.4
BI 3006337 50 mg
40100
± 44.2
BI 3006337 100 mg
71300
± 37.9
BI 3006337 150 mg
80600
± 34.6
Maximum Measured Concentration of BI 3006337 in Serum (Cmax)Secondary· 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.
Group
Value
95% CI
BI 3006337 0.2 mg
1.78
± 43.5
BI 3006337 0.5 mg
4.38
± 75.1
BI 3006337 1 mg
4.70
± 34.2
BI 3006337 2 mg
14.5
± 63.7
BI 3006337 4 mg
37.3
± 79.3
BI 3006337 8 mg
50.8
± 18.7
BI 3006337 15 mg
127
± 42.2
BI 3006337 30 mg
220
± 37.5
BI 3006337 50 mg
642
± 49.6
BI 3006337 100 mg
788
± 63.0
BI 3006337 150 mg
1290
± 54.6
Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax)Secondary· 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.
Group
Value
95% CI
BI 3006337 0.2 mg
7.0
7.0 – 27.1
BI 3006337 0.5 mg
15.0
7.0 – 23.1
BI 3006337 1 mg
11.0
7.0 – 72.0
BI 3006337 2 mg
15.0
7.0 – 35.0
BI 3006337 4 mg
11.0
11.0 – 15.1
BI 3006337 8 mg
13.0
11.0 – 23.2
BI 3006337 15 mg
11.0
7.0 – 11.1
BI 3006337 30 mg
13.0
11.0 – 31.0
BI 3006337 50 mg
11.0
11.0 – 27.0
BI 3006337 100 mg
61.5
11.1 – 96.4
BI 3006337 150 mg
11.0
7.0 – 35.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From 1 day pre-dose till end of trial, up to 40 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 8 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05076422.