This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers. The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
CMAX Clinical Research Pty Ltd
Adelaide, Australia
Number of subjects with adverse events
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events
Time frame: Between screening and 7-9 days after dosing
Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
Time frame: Between screening and 7-9 days after dosing
Cmax
Maximum (peak) plasma drug concentration
Time frame: From the start of administration to 24 hours after administration
Tmax
Time to reach maximum (peak) plasma concentration following drug administration
Time frame: From the start of administration to 24 hours after administration
t1/2
Elimination half-life
Time frame: From the start of administration to 24 hours after administration
AUC0-t
Area under the plasma concentration-time curve from time zero to time t.
Time frame: From the start of administration to 24 hours after administration
AUC0-inf
Area under the plasma concentration-time curve from time zero to infinity
Time frame: From the start of administration to 24 hours after administration
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CL
Apparent total body clearance of the drug from plasma
Time frame: From the start of administration to 24 hours after administration
Vd
Apparent volume of distribution
Time frame: From the start of administration to 24 hours after administration