Trials / Completed
CompletedNCT03707717
A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer Participants
An Open-Label, Multicenter, Randomized, Parallel-Group, 3-Arm, Single-Dose Bioequivalence Study of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-Injector in Adult Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 189 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ delivery devices in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bimekizumab | Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period. |
Timeline
- Start date
- 2018-10-15
- Primary completion
- 2019-06-05
- Completion
- 2019-06-05
- First posted
- 2018-10-16
- Last updated
- 2020-06-16
Locations
2 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03707717. Inclusion in this directory is not an endorsement.