A SINGLE CENTER, RANDOMIZED, INVESTIGATOR- AND PARTICIPANT-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, ETHNOBRIDGING PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS AFTER SINGLE-DOSE OF UCB9741 IN HEALTHY CAUCASIAN AND JAPANESE PARTICIPANTS

UP0118

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.

2024-07-01

2025-07-29

2025-07-29

Not yet recruiting

Early phase I

50

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

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2024-04-16