A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants

NCT ID: NCT06315335

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-01-01

Brief Summary

The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1 (Caucasian)

Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo

Group Type: EXPERIMENTAL

UCB9741

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.

Placebo

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.

Cohort 2 (Japanese)

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo

Group Type: EXPERIMENTAL

UCB9741

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.

Placebo

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.

Cohort 3 (Caucasian)

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo

Group Type: EXPERIMENTAL

UCB9741

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.

Placebo

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.

Cohort 4 (Japanese)

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo

Group Type: EXPERIMENTAL

UCB9741

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.

Placebo

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.

Cohort 5 (Caucasian)

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 (using a different volume per injection than cohort 3) or Placebo

Group Type: EXPERIMENTAL

UCB9741

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.

Placebo

Intervention Type: DRUG

Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.

Interventions

UCB9741

Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.

Intervention Type: DRUG

Placebo

Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For all subjects:

• Male or female between 18 to 55 years old, overtly healthy
• Female participants must not be pregnant or breastfeeding
• Female participants must be either of non-childbearing potential or using a highly efficient birth control method
• Male participants must use acceptable contraception and refrain from sperm donation during the study 90 days
• Body mass Index within the range 18 to 30 kg/m^2 (inclusive)

For Japanese subjects only:

Japanese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Japanese descent with all 4 grandparents

For Caucasian subjects only:

Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage and is of Caucasian descent with all 4 grandparents

Exclusion Criteria

• Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs or humanized antibodies (mAbs)
• Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
• Participant has abnormal blood pressure (BP) (outside the normal range)
• Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.5x upper limit of normal (ULN)
• Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)
• Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
• Participant has a history of diabetes
• Study participant has a corrected QT interval (QTc) >450msec for male study participants or >470msec for female study participants
• Participant has sensitivity to heparin or heparin-induced thrombocytopenia
• Participant has a positive test for substance of abuse, or is a regular alcohol consumer defined as an average weekly intake of >14 units
• Participant has received any prescription or nonprescription medicines within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than contraceptives or occasional use of analgesic
• Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of investigational medicinal product (IMP)
• Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit
• Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of the IMP (whichever longer), or is currently participating in another study of an IMP

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Up0118 10001

Glendale, California, United States

Countries

United States

Other Identifiers

UP0118

Identifier Type: -

Identifier Source: org_study_id