This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
66
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
AE/serious AE
Adverse event/serious adverse event
Time frame: From screening up to 3 weeks
Vital signs: Systolic and Diastolic Blood Pressure
Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers.
Time frame: From screening up to 3 weeks
Ramsay sedation score
Ramsay sedation score will be collected
Time frame: -60 minutes before administration until 24 hours after administration
Visual analog scale (VAS) addiction score
VAS addiction score will be collected
Time frame: from administration to 24 hours after administration
Peak concentration (Cmax)
Cmax(a measure of the body's exposure to HSK21542)will be calculated in healthy volunteers.
Time frame: -30 minutes before administration until 24 hours after administration
Area under the concentration-time curve(AUC)
AUC(a measure of the body's exposure to HSK21542)will be calculated in healthy volunteers.
Time frame: -30 minutes before administration until 24 hours after administration
Tmax
time to peak observed
Time frame: -30 minutes before administration until 24 hours after administration
Total clearance
Total clearance
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Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Time frame: -30 minutes before administration until 24 hours after administration
Prolactin level
Prolactin level will be collected
Time frame: before administration until 24 hours after administration
Antidiuretic hormone level
Antidiuretic hormone level will be collected
Time frame: before administration until 24 hours after administration
Urine volume
Urine volume will be collected
Time frame: before administration until 24 hours after administration