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

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 1

Conditions

Sedation

Anesthesia

Treatments

Drug: HSK3486

Drug: Propofol

Study type

Interventional

Funder types

Industry

Identifiers

NCT04037657

HSK3486-Australian-02

Details and patient eligibility

About

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).

Enrollment

25 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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.