A Study to Assess the Safety and Pharmacokinetics of a Si... | NCT06315335

NCT06315335

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1 (Caucasian)	Experimental	Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo	Drug: UCB9741 Drug: Placebo
Cohort 2 (Japanese)	Experimental	Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo	Drug: UCB9741 Drug: Placebo
Cohort 3 (Caucasian)	Experimental	Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo	Drug: UCB9741 Drug: Placebo
Cohort 4 (Japanese)	Experimental	Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo	Drug: UCB9741 Drug: Placebo
Cohort 5 (Caucasian)	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UCB9741	Drug	Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.	Cohort 1 (Caucasian) Cohort 2 (Japanese) Cohort 3 (Caucasian)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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