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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: UCB9741; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 1-844-599-2273 (USA); Email: UCBCares@ucb.com
• Study Contact Backup: Name: UCB Cares; Phone Number: 0018445992273; Email: ucbcares@ucb.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (Caucasian); Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo	Drug: UCB9741; Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.; Drug: Placebo; Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.
Experimental: Cohort 2 (Japanese); Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo	Drug: UCB9741; Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.; Drug: Placebo; Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.
Experimental: Cohort 3 (Caucasian); Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo	Drug: UCB9741; Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.; Drug: Placebo; Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.
Experimental: Cohort 4 (Japanese); Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo	Drug: UCB9741; Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.; Drug: Placebo; Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.
Experimental: 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	Drug: UCB9741; Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.; Drug: Placebo; Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of TEAEs	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharamceutical product administration or an already present event that worsens either in intensity or frequency	From Baseline Visit up to the End of Study Visit (Week 8)
Occurrence of treatment-emergent SAEs	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above	From Baseline up to the End of Study Visit (Week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Cmax: Maximum serum concentration	From Day 1 (predose) up to the End of Study Visit (Week 8)
AUC0-t	AUC0-t: Area under the curve from 0 to the time of the last quantifiable concentration	From Day 1 (predose) up to the End of Study Visit (Week 8)
AUCinf	AUCinf: Area under the curve from 0 to infinity	From Day 1 (predose) up to the End of Study Visit (Week 8)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 29, 2025
• Study Completion (Estimated): July 29, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Phase 1; UCB9741
• Other Study ID Numbers: UP0118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No