Anesthesia Clinical Trial
Official title:
A Phase 1b, Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Dose of HSK3486 in Healthy Female Subjects.
Verified date | December 2015 |
Source | Sichuan Haisco Pharmaceutical Group Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 25 |
Est. completion date | November 13, 2015 |
Est. primary completion date | June 9, 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sichuan Haisco Pharmaceutical Group Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety by measurement of Adverse Events | First dose of study drug on day 1 | ||
Primary | Bispectral index (BIS) | From first dose of study drug until fully alert on day 1 | ||
Primary | Modified observer's assessment of alertness/sedation(MOAA/S) | Observe the change of modified observer's assessment of alert /sedation during the whole trial | Time Frame: From first dose of study drug until fully alert on day 1 | |
Secondary | Median effective dose (ED50) | From first dose of study drug until fully alert on day 1 | ||
Secondary | Peak concentration (Cmax) | From the start of administration to 48 hours after administration | ||
Secondary | Time to plasma peak concentration(Tmax) | From the start of administration to 48 hours after administration | ||
Secondary | Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf) | From the start of administration to 48 hours after administration | ||
Secondary | Total clearance (CL) | From the start of administration to 48 hours after administration |
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