Clinical Trials Directory

Trials / Terminated

TerminatedNCT04255862

A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants

An Open-Label, Single-Center, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
71 (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) of bimekizumab when administered subcutaneously (sc) as 1x2 mL versus 2x1 mL, using a bimekizumab-safety syringe presentation or bimekizumab-auto-injector presentation, in healthy study participants.

Conditions

Interventions

TypeNameDescription
DRUGBimekizumabStudy participants will receive a single-dose of bimekizumab administered subcutaneously in the Treatment Period.

Timeline

Start date
2020-02-12
Primary completion
2021-04-26
Completion
2021-04-26
First posted
2020-02-05
Last updated
2025-04-10
Results posted
2025-04-10

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04255862. Inclusion in this directory is not an endorsement.