A Study to Evaluate the Relative Bioavailability and Tolerability of Bimekizumab in Healthy Subjects

NCT ID: NCT05028127

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-04
• Study Completion Date: 2016-06-17

Brief Summary

The purpose of the study to determine the relative bioavailability of bimekizumab in healthy subjects

Conditions

Healthy Volunteers

Keywords

Bimekizumab; Phase 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bimekizumab dosage regimen 1

Subjects participating in the study will be receiving assigned bimekizumab dosage regimen 1 during the Treatment Period.

Group Type: EXPERIMENTAL

Bimekizumab

Intervention Type: DRUG

Subjects will be receiving bimekizumab at pre-specified time-points.

Bimekizumab dosage regimen 2

Subjects participating in the study will be receiving assigned bimekizumab dosage regimen 2 during the Treatment Period.

Group Type: EXPERIMENTAL

Bimekizumab

Intervention Type: DRUG

Subjects will be receiving bimekizumab at pre-specified time-points.

Interventions

Bimekizumab

Subjects will be receiving bimekizumab at pre-specified time-points.

Intervention Type: DRUG

Other Intervention Names

UCB4940; BKZ

Eligibility Criteria

Inclusion Criteria

• Subject is male or female aged ≥18 years and ≤65 years at the Screening Visit
• Female subjects of child bearing potential must have a negative serum pregnancy test at the Screening Visit, which is confirmed to be negative by urine testing prior to the first dose of the Investigational Medicinal Product (IMP). Female subjects of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 20 weeks after their last dose of the IMP
• Subject must be in good health (physically and mentally) as determined by the Investigator on the basis of medical history (any chronic and acute illness), physical examination, vital signs, 12-lead ECG, and laboratory screening tests during the Screening Period
• Subject has a body weight of 45 to 90 kg (inclusive) and body mass index (BMI) between 19 and 28 kg/m^2 (inclusive)

Exclusion Criteria

• Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method. Male subjects who are planning a partner pregnancy during the study
• Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 20 weeks after the last dose of study drug
• Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration
• Subject has a known hypersensitivity to any components of the IMP as stated in this protocol
• Subject has a current or past history of gastrointestinal ulceration or other gastrointestinal disease
• Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms, and/or requires therapy to maintain stable status
• Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration
• Study participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at the Screening Visit
• Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
• Subject has 12-lead ECG with changes considered to be clinically significant at Screening Visit and Day -1
• Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening Visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Celltech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

UP0031

Identifier Type: -

Identifier Source: org_study_id