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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: UCB9741; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06315335

UP0118

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

Cohort 1 (Caucasian)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: UCB9741

Cohort 2 (Japanese)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: UCB9741

Cohort 3 (Caucasian)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: UCB9741

Cohort 4 (Japanese)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: UCB9741

Cohort 5 (Caucasian)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: UCB9741