At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 200 enrolled
Drug / intervention
BI 695501 - higher concentration +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating BI 695501 - higher concentration and BI 695501 - lower concentration for Healthy. Completed, enrolled 200 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedJan 2022
Enrollment StartFeb 2022
Primary CompletionAug 2022
TodayJul 2026
First PostedJan 24, 2022
Enrollment StartFeb 18, 2022
Primary CompletionAug 29, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.4 years ago
Interventions
BI 695501 - higher concentrationdrug
BI 695501 - higher concentration
BI 695501 - lower concentrationdrug
BI 695501 - lower concentration