Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects.

NCT ID: NCT04037657

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-22
• Study Completion Date: 2015-11-13

Brief Summary

This study was a single-center positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Intensive safety, PD and PK assessments were performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

Conditions

Anesthesia; Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HSK3486

0.288 mg/kg ，0.432 mg/kg ，0.540 mg/kg ，0.648 mg/kg，0.810 mg/kg There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).

Group Type: EXPERIMENTAL

HSK3486

Intervention Type: DRUG

HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).

Propofol

2.5 mg propofol

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump.

Interventions

HSK3486

HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).

Intervention Type: DRUG

Propofol

Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female, aged 18 - 49 years (inclusive)
• Women of child-bearing potential agreed to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
• Negative serum pregnancy test
• In general good health without CS medical history
• American Society of Anesthesiologists (ASA) Physical Status Classification of I or II
• Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive)
• Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBs-Ag), hepatitis C virus antibody (HCV-Ab) and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1
• Normal or non-CS findings on a physical examination, 12-lead Electrocardiogram (ECG) and vital signs (respiratory rate between 12 and 20 breaths per minute, blood pressure (BP) between 100-140/60-90 mmHg, heart rate between 50-99 beats per minute, temperature between 35.8°C and 37.5°C and pulse oximetry values > 95% on room air)
• Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the PI decided that out-of-range values were not CS
• Able to provide written informed consent
• Willing and able to follow study instructions and likely to complete all study requirements
• Suitable venous and arterial access

Exclusion Criteria

• History of allergy or sensitivity to: propofol, components of Fresofol 1% MCT/LCT propofol, or HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine
• History of CS problems with general anesthesia
• Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening
• History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months CONFIDENTIAL HSK3486 SAD_02 Sichuan Haisco Pharmaceutical Co., Ltd Version: 13 Nov 2015 Page 19 of 513
• Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of contraceptive medications, paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the PI and Sponsor.
• Standard donation of blood within 30 days of the study
• Donation of plasma or participation in a plasmapheresis program within 7 days preceding this study
• Receipt of any investigational study drug within 30 days prior to screening
• Unable to fast for the 6 hours prior to Investigational Product administration
• CS (as judged by the Investigator) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the clinical study unit
• Anticipated need for surgery or hospitalization during the study
• Anatomical abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia
• History of posture-related gastric reflux more than twice weekly
• History of seizures or epilepsy
• History of ischaemic heart disease
• History of brady- or tachy-dysrhythmias requiring medical care
• History of asthma, with bronchospasm requiring treatment in the last 3 months
• Any condition, which in the Investigator's opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HSK3486-Australian-02

Identifier Type: -

Identifier Source: org_study_id