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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315335
• Other study ID #: UP0118
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2024
• Est. completion date: July 29, 2025

Study information

• Verified date: April 2024
• Source: UCB Pharma
• Contact: UCB Cares
• Phone: 1-844-599-2273 (USA)
• Email: ucbcares[@]ucb.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 29, 2025
• Est. primary completion date: July 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Cmax	Cmax: Maximum serum concentration	From Day 1 (predose) up to the End of Study Visit (Week 8)
Secondary	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)
Secondary	AUCinf	AUCinf: Area under the curve from 0 to infinity	From Day 1 (predose) up to the End of Study Visit (Week 8)