A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer Participants

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
UCB Biopharma S.P.R.L.
Study ID
NCT03707717
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Bimekizumab — DRUG
    Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.

Study Details

The purpose of the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ delivery devices in healthy participants.

Key Dates

Start date
Oct 15, 2018
Status verified
Jun 2020
Primary completion
Jun 5, 2019
Completion
Jun 5, 2019

Study Design

Enrollment
189 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Bimekizumab-SS
    Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe.
  • Experimental: Bimekizumab-AI
    Subjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector.
  • Experimental: Bimekizumab-TN
    Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device.

Primary Outcome Measure

Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax) [ Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Up0033 002BaltimoreMaryland21225-

Find similar trials in Baltimore, MD

By research site
Up0033 002· Baltimore, MD

Related Studies