Clinical trial NCT06315335: A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Phase 1
UCB9741
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Occurrence of TEAEs
timeFrame: From Baseline Visit up to the End of Study Visit (Week 8)
measure: Occurrence of treatment-emergent SAEs
timeFrame: From Baseline up to the End of Study Visit (Week 8)
Secondary outcomes:
measure: Cmax
timeFrame: From Day 1 (predose) up to the End of Study Visit (Week 8)
measure: AUC0-t
timeFrame: From Day 1 (predose) up to the End of Study Visit (Week 8)
measure: AUCinf
timeFrame: From Day 1 (predose) up to the End of Study Visit (Week 8)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Up0118 10001
state: California
Study officials:
References: