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

Sponsor
UCB Biopharma SRL
Study ID
NCT04255862
Phase
PHASE1
Status
Terminated

Conditions

  • Healthy Study Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 12, 2020
Status verified
Mar 2025
Primary completion
Apr 26, 2021
Completion
Apr 26, 2021

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Test 1
    Study participants randomized to this arm will receive bimekizumab administered subcutaneously with bimekizumab-safety syringe-2 mL presentation (test 1).
  • Other: Reference 1
    Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-safety syringe-1 mL presentation (reference 1).
  • Experimental: Test 2
    Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-auto-injector-2 mL presentation (test 2).
  • Other: Reference 2
    Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-auto-injector-1 mL (reference 2).

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ) [ Time Frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140) ]

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