Trial Outcomes & Findings for Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery (NCT NCT05486416)

Last Updated: 2025-10-10

Results Overview

1. Induction success (MOAA/S ≤1) after administration of the study drug, and 2. One or less top-up doses required without using any rescue drugs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

465 participants

Primary outcome timeframe

From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1( up to 5 minutes)

Results posted on

2025-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	HSK3486 HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Overall Study STARTED	313	152
Overall Study Dosed	300	145
Overall Study Full Analysis Set	300	145
Overall Study Safety Set	300	145
Overall Study COMPLETED	300	145
Overall Study NOT COMPLETED	13	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HSK3486 for General Anesthesia Induction n=300 Participants HSK3486 for induction of general anesthesia HSK3486: HSK3486 for induction of general anesthesia	Propofol for General Anesthesia Induction n=145 Participants Propofol for induction of general anesthesia Propofol: Propofol for induction of general anesthesia	Total n=445 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	229 Participants n=5 Participants	110 Participants n=7 Participants	339 Participants n=5 Participants
Age, Categorical >=65 years	71 Participants n=5 Participants	35 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	74 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	71 Participants n=7 Participants	198 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	91 Participants n=5 Participants	38 Participants n=7 Participants	129 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	204 Participants n=5 Participants	107 Participants n=7 Participants	311 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	38 Participants n=5 Participants	23 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) White	254 Participants n=5 Participants	114 Participants n=7 Participants	368 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	234 participants n=5 Participants	119 participants n=7 Participants	353 participants n=5 Participants
Region of Enrollment Poland	27 participants n=5 Participants	15 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Spain	39 participants n=5 Participants	11 participants n=7 Participants	50 participants n=5 Participants
ASA-PS ASA-PS I	47 Participants n=5 Participants	24 Participants n=7 Participants	71 Participants n=5 Participants
ASA-PS ASA-PS II	183 Participants n=5 Participants	90 Participants n=7 Participants	273 Participants n=5 Participants
ASA-PS ASA-PS III	70 Participants n=5 Participants	31 Participants n=7 Participants	101 Participants n=5 Participants
BMI <35kg/m^2	237 Participants n=5 Participants	113 Participants n=7 Participants	350 Participants n=5 Participants
BMI ≥35kg/m^2	63 Participants n=5 Participants	32 Participants n=7 Participants	95 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1( up to 5 minutes)

Population: Completed primary efficacy measurement

1. Induction success (MOAA/S ≤1) after administration of the study drug, and 2. One or less top-up doses required without using any rescue drugs.

Outcome measures

Outcome measures
Measure	HSK3486 n=300 Participants HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=145 Participants Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Success Rate of General Anesthesia Induction	298 Participants	143 Participants

SECONDARY outcome

Timeframe: 15 minutes from end of drug administration

The outcome is defined by all the following conditions: a) Desired depth of anesthesia for general elective surgery is defined if all following criteria are met: i) No clinical signs of inadequate depth of anesthesia, such as lacrimation, movement, vomiting, coughing, laryngospasm, bucking, swallowing reflex or bronchospasm etc. ii) No blood pressure (SBP, DBP, or MAP) increases more than 20% from baseline in response to any major operational procedures or noxious stimulus in defined period. iii) Subjects maintain desired depth of anesthesia for general elective surgery with BIS as an objective assessment (after reaching initial lowest value, BIS remains sustainable level at not more than 60). b) No significant respiratory depression, such as apnea, prior to the administration of rocuronium bromide. c) No significant cardiac depression indicated by blood pressure decrease that requires intervention, i.e., vasopressors and/or IV fluid resuscitation.

Outcome measures

Outcome measures
Measure	HSK3486 n=300 Participants HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=145 Participants Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Percentage of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression	81 Participants	45 Participants

SECONDARY outcome

Timeframe: From start of the drug administration to MOAA/S ≤1 (up to 3 minutes)

0 = No Pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-9 = Severe Pain 10 = Worst pain imaginable

Outcome measures

Outcome measures
Measure	HSK3486 n=300 Participants HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=145 Participants Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1	56 Participants	86 Participants

Adverse Events

HSK3486 for General Anesthesia Induction

Serious events: 5 serious events

Other events: 185 other events

Deaths: 1 deaths

Propofol for General Anesthesia Induction

Serious events: 1 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HSK3486 for General Anesthesia Induction n=300 participants at risk HSK3486 for induction of general anesthesia HSK3486: HSK3486 for induction of general anesthesia	Propofol for General Anesthesia Induction n=145 participants at risk Propofol for induction of general anesthesia Propofol: Propofol for induction of general anesthesia
Psychiatric disorders Confusional state	0.33% 1/300 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Hepatobiliary disorders Cholelithiasis	0.33% 1/300 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Respiratory, thoracic and mediastinal disorders Mediastinal hematoma	0.00% 0/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.69% 1/145 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Injury, poisoning and procedural complications Urecteric injury	0.33% 1/300 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Vascular disorders Internal hemorrhage	0.33% 1/300 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Infections and infestations Wound dehiscence	0.33% 1/300 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Infections and infestations Peritonitis	0.33% 1/300 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Infections and infestations Septic Shock	0.33% 1/300 • Number of events 1 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.

Other adverse events

Other adverse events
Measure	HSK3486 for General Anesthesia Induction n=300 participants at risk HSK3486 for induction of general anesthesia HSK3486: HSK3486 for induction of general anesthesia	Propofol for General Anesthesia Induction n=145 participants at risk Propofol for induction of general anesthesia Propofol: Propofol for induction of general anesthesia
Vascular disorders Hypotension	18.3% 55/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	22.1% 32/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Vascular disorders Hypertension	8.0% 24/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	6.2% 9/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Injury, poisoning and procedural complications Procedural Hypotension	11.3% 34/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	15.9% 23/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Injury, poisoning and procedural complications Procedural Pain	3.0% 9/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	4.1% 6/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Injury, poisoning and procedural complications Procedural nausea	1.3% 4/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	3.4% 5/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Gastrointestinal disorders Nausea	16.0% 48/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	11.7% 17/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Nervous system disorders Constipation	1.0% 3/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	6.9% 10/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Cardiac disorders Tachycardia	4.3% 13/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	4.8% 7/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Investigations Electrocardiogram QT prolonged	0.67% 2/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	3.4% 5/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Renal and urinary disorders Haematuria	1.3% 4/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	4.1% 6/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.7% 5/300 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	3.4% 5/145 • AEs will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.

Additional Information

Yu-Ling Lai

Haisco-USA Pharmaceuticals, Inc.

Phone: 858-263-4239

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60