MedTrace Logo

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

NCT04255862 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-04-10

Study results available
· View outcomes & findings →

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

  • Healthy Study Participants

Interventions

DRUG

Bimekizumab

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

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2021-04-26
Completion
2021-04-26

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255862 on ClinicalTrials.gov