Efficacy and Safety of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults Undergoing Elective Surgery.

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Haisco-USA Pharmaceuticals, Inc.
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Subjects undergoing elective surgery (nonemergency, noncardiothoracic, and nonintracranial surgery anticipated to last at least 1 hour ).

• Males or females, aged ≥18 years old, with American Society of Anesthesiologists Physical Status (ASA PS) I to IV.

• Body mass index (BMI) ≥18 kg/m2.

• For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device [IUD], abstinence) from the time of consent until 30 days post study drug administration.

• Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form, and to complete this study in strict compliance with the study protocol.

Exclusion Criteria:

• Contraindications to deep sedation/general anesthesia or a history of adverse reaction to sedation/general anesthesia.

• Known to be allergic to eggs, soy products, opioids and their antidotes, or propofol; subject having contraindications to propofol, opioids, and their antidotes.

• Medical condition or evidence of increased sedation/general anesthesia risk.

• Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study.

• Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics.

• Laboratory parameters significantly out of range at screening.

• Female subjects with a positive pregnancy test (serum or urine) at screening or baseline; lactating subjects; any subject planning to get pregnant within 1 month after the study (including the male subject's partner).

• Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.