NCT05292131

A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Study Participants

Interventions

Type	Name	Description
DRUG	bimekizumab	Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.

Timeline

• Start date: 2022-03-17
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2022-03-23
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study