A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in Healthy Participants
NCT Number: NCT06555601
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: UCB3101|DRUG: Placebo
Sponsor: UCB Biopharma SRL
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-31
Completion Date: 2026-01-08
Locations: UP0124 1, Edegem, Belgium

Summary:
The purpose of the study is to evaluate the safety and tolerability of a single ascending dose of UCB3101 in cohorts of healthy male and female study participants.

Primary Outcome Measures: Incidence of any treatment- emergent adverse events (TEAE), 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., From Baseline to Safety Follow-up (up to Week 21)
Secondary Outcome Measures: Incidence of any treatment-emergent Serious Adverse Events (SAE), A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

* Results in death;
* Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization;
* 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 to Safety Follow-up (up to Week 21)|Incidence of discontinuation from treatment due to treatment- emergent adverse events (TEAE), 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., From Baseline to Safety Follow-up (up to Week 21)|Changes from Baseline at each time point in vital signs (blood pressure), Blood pressure will be measured in millimeters of mercury (mmHg)., From Baseline up to Safety Follow-up (up to Week 21)|Changes from Baseline at each time point in vital signs (pulse rate), Pulse rate will be measured in beats per minute (beats/min)., From Baseline up to Safety Follow-up (up to Week 21)|Changes from Baseline at each time point in vital signs (body temperature), Temperature will be measured in degrees Celsius (°C)., From Baseline up to Safety Follow-up (up to Week 21)|Number of participants with abnormal laboratory test results (hematology), Safety laboratory assessments including blood tests for hematology will be performed., From Baseline to Safety Follow-up (up to Week 21)|Number of participants with abnormal laboratory test results (clinical chemistry), Safety laboratory assessments including blood tests for clinical chemistry will be performed., From Baseline to Safety Follow-up (up to Week 21)|Number of participants with abnormal laboratory test results (urinalysis), Safety laboratory assessments including urine tests for urinalysis will be performed., From Baseline to Safety Follow-up (up to Week 21)|Number of participants with abnormal 12-lead Electrocardiogram (ECG) assessment, Triplicate 12-lead ECG will be performed., From Baseline to Safety Follow-up (up to Week 21)|Number of participants with abnormal physical examination findings, including neurological examination findings, Changes from Baseline in physical examination findings, including neurological examination findings will be reported., From Baseline up to Safety Follow-up (up to Week 21)|Maximum Serum Concentration (Cmax) of UCB3101, Maximum serum concentration (Cmax) of UCB3101 will be reported., From Day 1 (Predose) up to Week 21|Area Under the Concentration-Time Curve (AUC) of UCB3101, Area under the concentration-time curve (AUC) of UCB3101 will be reported., From Day 1 (Predose) up to Week 21