At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 121 enrolled
Drug / intervention
bimekizumabdrug
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.
An Open-Label, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
In Brief
A Phase 1 clinical trial evaluating bimekizumab for Healthy Study Participants. Completed, enrolled 121 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to compare the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Study Participants
CountriesGermany, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartMar 2022
First PostedMar 2022
Primary CompletionJan 2023
TodayJul 2026
First PostedMar 23, 2022
Enrollment StartMar 17, 2022
Primary CompletionJan 9, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.3 years ago
Interventions
bimekizumabdrug
Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.