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This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II clinical study. The main objective is to evaluate the efficacy and safety of HSK21542 injection and explore the recommended dose and administration frequency for subsequent Phase II studies in conjunction with the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics.
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Inclusion criteria
Exclusion criteria
History of allergy to opioids, such as urticaria, or allergic to the intraoperative anesthetics prescribed in the protocol;
History or evidence of any one of the following diseases prior to screening:
Any of the following airway management risks during screening:
In receipt of any of the following drugs or therapies during the screening period:
Laboratory test parameters meet one of the following criteria in the screening period and is confirmed by retests:
Without oxygen supplement during the screening period, the pulse oxygen saturation is < 92%;
During the screening period, the virological examination for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody is positive;
History of drug abuse, narcotics use and/or alcohol abuse within 3 months before screening. Alcohol abuse is defined as > 2 units of alcohol consumption per day (1 unit = 360 mL of beer containing 5% alcohol, 45 mL of liquor containing 40% alcohol, or 150 mL of wine);
Donated or lost ≥ 400 mL of blood within 3 months before screening;
Participated in any drug clinical trials within 3 months before screening (defined as the administration of the investigational product or placebo);
Women who are pregnant or breastfeeding; fertile women or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 3 month after the completion of the trial (including male subjects);
Subjects determined by the investigator to be unsuitable for participating in this clinical study for any other reason.
Primary purpose
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Interventional model
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124 participants in 7 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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