This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period. This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
single subcutaneous injection of ASC47
single subcutaneous injection of Placebo
Ascletis
Herston, Queensland, Australia
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.
Time frame: up to 57 days
ECG QT Interval
Evaluate the ECG QT Interval after single doses of ASC47.
Time frame: up to 57 days
Blood cell
Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.
Time frame: up to 57 days
Hematology
Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
Time frame: up to 57 days
AUC of ASC47
Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.
Time frame: up to 57 days
Cmax of ASC47
Evaluate the Peak Plasma Concentration after single doses of ASC47.
Time frame: up to 57 days
Cmin of ASC47
Evaluate the Minimum Plasma Concentration after single doses of ASC47.
Time frame: up to 57 days
T1/2 of ASC47
Evaluate the Terminal-Phase Half-Life after single doses of ASC47
Time frame: up to 57 days
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CL/F of ASC47
Evaluate the Apparent Systemic Clearance after single doses of ASC47.
Time frame: up to 57 days
Vd/F of ASC47
Evaluate the Apparent Volume of Distribution after single doses of ASC47.
Time frame: up to 57 days
Lipid parameters
Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.
Time frame: up to 57 days