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

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 (BKZ) administered subcutaneously in the Treatment Period.

Study Details

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.

Key Dates

Start date

Mar 17, 2022

Status verified

Mar 2025

Primary completion

Jan 9, 2023

Completion

Jan 9, 2023

Study Design

Enrollment

121 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Test
  Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).
• Other: Reference
  Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).

Primary Outcome Measure

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

Locations (1)

Related coverage on Hipa.ai

• Bimekizumab Bioequivalence Study Shows Similar PK for Autoinjector Formulations
  Bimekizumab · Apr 10, 2025 · ClinicalTrials.gov

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