Up0118 10001
Glendale, California, 91206, United States
NCT Number: NCT06315335
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all subjects:
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
Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.
Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.
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
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
Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)
Cmax: Maximum serum concentration
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
Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)
AUCinf: Area under the curve from 0 to infinity
UCB Biopharma SRL
Industry
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
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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