A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants
- Registration Number
- NCT06315335
- Lead Sponsor
- UCB Biopharma SRL
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 (Caucasian) UCB9741 Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo Cohort 1 (Caucasian) Placebo Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo Cohort 2 (Japanese) UCB9741 Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo Cohort 2 (Japanese) Placebo Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo Cohort 3 (Caucasian) UCB9741 Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo Cohort 3 (Caucasian) Placebo Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo Cohort 4 (Japanese) UCB9741 Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo Cohort 4 (Japanese) Placebo Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo Cohort 5 (Caucasian) UCB9741 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 Cohort 5 (Caucasian) Placebo 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
- Primary Outcome Measures
Name Time Method Occurrence of TEAEs 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
Occurrence of treatment-emergent SAEs 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 Outcome Measures
Name Time Method AUC0-t 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
Cmax From Day 1 (predose) up to the End of Study Visit (Week 8) Cmax: Maximum serum concentration
AUCinf From Day 1 (predose) up to the End of Study Visit (Week 8) AUCinf: Area under the curve from 0 to infinity
Trial Locations
- Locations (1)
Up0118 10001
🇺🇸Glendale, California, United States