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OpenTrials
Completed

NCT Number: NCT06315335

A Study to Assess the Safety and Pharmacokinetics of a 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Up0118 10001

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCB9741

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Occurrence of TEAEs

    Time frame: From Baseline Visit up to the End of Study Visit (Week 8)

    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

  2. Occurrence of treatment-emergent SAEs

    Time frame: From Baseline up to the End of Study Visit (Week 8)

    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

Secondary outcomes

  1. Cmax

    Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)

    Cmax: Maximum serum concentration

  2. AUC0-t

    Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)

    AUC0-t: Area under the curve from 0 to the time of the last quantifiable concentration

  3. AUCinf

    Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)

    AUCinf: Area under the curve from 0 to infinity

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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