Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects
A Phase 1 Study Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects: Single Ascending Dose (SAD) in Males and Postmenopausal Females and Multiple Ascending Dose (MAD) in Males and Females of Non-childbearing Potential
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
39
Syneos Clinical Research Unit
Québec, Quebec, Canada
Incidence and Number of Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.The incidence and number of patients who experience an AE will be reported.
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Area under concentration time curve (AUC) zero to t
Blood samples will be collected to determine the Area under the concentration-time curve from time zero until the last observed concentration
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Area under concentration time curve (AUC) zero-infinity
Blood samples will be collected to determine the Area under the concentration-time curve from time zero to infinity (extrapolated)
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Maximum observed Plasma Concentration (Cmax)
Blood samples will be collected to determine Cmax
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Time to maximum concentration (Tmax)
Blood samples will be collected to determine Tmax
Time frame: up to 106 days for Single dose and 147 days for multiple doses
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