Trials / Completed
CompletedNCT05203289
A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection
Relative Bioavailability of 40 mg/0.4 mL of BI 695501 Compared to 40 mg/0.8 mL of BI 695501 Formulation Following Single Subcutaneous Administration in Healthy Male and Female Subjects (a Double Blind, Randomised, Single-dose, Parallel-arm Study)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 695501 - higher concentration | BI 695501 - higher concentration |
| DRUG | BI 695501 - lower concentration | BI 695501 - lower concentration |
Timeline
- Start date
- 2022-02-18
- Primary completion
- 2022-08-29
- Completion
- 2022-08-29
- First posted
- 2022-01-24
- Last updated
- 2024-03-15
- Results posted
- 2024-03-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05203289. Inclusion in this directory is not an endorsement.