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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
Up0118 10001
Glendale, California, United States
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
Time frame: 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
Time frame: From Baseline up to the End of Study Visit (Week 8)
Cmax
Cmax: Maximum serum concentration
Time frame: 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
Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)
AUCinf
AUCinf: Area under the curve from 0 to infinity
Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)
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