AnesthesiaPhase 1NCT03745625
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486
A Phase 1 study testing HSK3486 and Propofol in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Sedation
- What is being tested?
- HSK3486 and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2019to 27 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females with full capacity for civil conduct, aged ≥ 18 and ≤ 49 years old;
- Body weight > 45 kg, and body mass index (BMI) ≥ 19 and ≤26 kg/m2;
- Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 °C; respiration rate between 12-20 breaths per minute; SpO2 when inhaling > 95%;
- Normal physical examinations, laboratory examinations (routine blood test, blood biochemistry and routine urinalysis), and 12-Lead ECG, or abnormal but without clinical significance; no potential difficult airway (modified Mallampati score I-III);
- No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; No history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with trial protocol.
Who cannot join
- Known sensitivity to propofol, excipients in propofol medium-/long-chain triglyceride emulsion injection, excipients in HSK3486 emulsion injection (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); history of drug allergies (including anesthetics), allergic diseases, or those with hyperactive immune response;
- History of drug abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine drug test during screening;
- Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year;
- Serious infection, trauma or major surgery within 4 weeks before screening; or acute disease with clinical significance (determined by the investigator) within 2 weeks before screening, including GI diseases or infections (such as respiratory or CNS infections);
- In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 3 days prior to screening;
- In receipt of prescription drugs, Chinese herbal medicines, over-the-counter drugs or food supplements (such as vitamins and calcium supplements) other than contraceptives, paracetamol, oral non-steroidal anti-inflammatory drugs, topical over-the-counter preparations, within 2 weeks prior to enrollment; unless the principal investigator (PI) and the sponsor agree that the medication has no effect on the safety and PK/PD results of the trial;
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- History of cardiovascular diseases such as: postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥ 450 ms (Fridericia's correction formula);
- Impaired respiratory function, history of obstructive pulmonary disease, history of asthma, sleep apnea syndromes; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute upper respiratory tract infection, and with obvious symptoms such as fever, wheezing, nasal congestion and cough within 1 week prior to baseline;
- History of GI tract diseases: Gastrointestinal obstruction, active GI bleed, potential for reflux and aspiration;
- Laboratory results that meet any of the following during screening/enrollment:
- Positive test for either HBsAg, HCV, HIV, or syphilis;
- Abnormal hepatic or renal function confirmed after re-examination;
- ALT or AST > 1×ULN;
- Creatinine > 1×ULN;
- TBIL > 1.5×ULN;
- History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive blood alcohol concentration during screening;
- Blood donation or blood loss ≥ 200 mL within 30 days before the trial; plasma donation or plasma exchange within 7 days before the trial;
- Subjects who continue to smoke, drink alcohol, or consume any food or beverages containing xanthine or caffeine, to participate in strenuous physical activities and other factors that may affect drug absorption, distribution, metabolism, and excretion within 2 days prior to enrollment; subjects who are unable to fast for 6 hours prior to dose administration;
- Subjects expected to have surgery or hospitalization during the trial;
- Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
- Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Randomized, Double-crossover, Propofol-controlled, Two-stage Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of IV Maintenance Dose After An Initial Dose and IV Single Loade Dose Plus Maintenance Dose of HSK3486 Emulsion fo Injection in Healthy Subjects
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
- Conditions
- Anesthesia, Sedation
- Being tested
- HSK3486, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
First-stage:after an initial dose of 1mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h.
Second-stage: a single loading dose of 0.2 mg/kg given over 1 minute, then a continuous infusion of maintenance dose 0.35 mg/kg/h for a total infusion time of 12h.
PropofolDrug
First-stage: after an initial dose of 5mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h.
Second-stage: loading dose of 1mg/kg given over 1 minute, then a continuous infusion of maintenance dose 1.75 mg/kg/h for a total infusion time of 12h.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | First-stage: 1mg/kg/h, 0.4mg/kg/h; Second-stage:Single loading dose: 0.2mg/kg, maintenance dose: 0.35mg/kg/h, Receives: Drug: HSK3486 |
| Propofol | Active comparator | First-stage: 5mg/kg/h, 2mg/kg/h; Second-stage:Single load ing dose: 1mg/kg, maintenance dose: 1.75mg/kg/h Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure（systolic, diastolic and mean arterial pressure）
safety endpoits
Measured: from the screening to 3 days post-dose
heart rate
safety endpoits
Measured: from the screening to 3 days post-dose
respiratory rate
safety endpoits
Measured: from the screening to 3 days post-dose
blood oxygen saturation
safety endpoits
Measured: from the screening to 3 days post-dose
Number of patients with adverse events
safety endpoits
Measured: from the baseline to 3 days post-dose
Secondary outcomes (7)
Richmond Agitation Sedation Scale( scores：+4~-5)
Change from baseline in Richmond Agitation Sedation Scale(RASS) score
Measured: -30 minutes before administration until the subject is completely awakened post administration on day 1
Bispectral index
Measured: -30 minutes before administration until the subject is completely awakened post administration on day 1
Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
Measured: -30 minutes before administration until the subject is completely awakened post administration on day 1
Terminal elimination half life
Measured: -30 minutes before administration until 24 hours post administration on day 1
Total clearance
Measured: -30 minutes before administration until 24 hours post administration on day 1
Volume of distribution
Measured: -30 minutes before administration until 24 hours post administration on day 1
plasma concentration at the end of infusion
Measured: -30 minutes before administration until 24 hours post administration on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start9 Jan 2019
- Primary completion2 Jul 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745625
- Sponsor's protocol ID
- HSK3486-102
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Double-crossover, Propofol-controlled, Two-stage Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of IV Maintenance Dose After An Initial Dose and IV Single Loade Dose Plus Maintenance Dose of HSK3486 Emulsion fo Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03745625
- Acronym / sponsor ID
- HSK3486-102
- Conditions
- Anesthesia, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK3486First-stage: 1mg/kg/h, 0.4mg/kg/h; Second-stage:Single loading dose: 0.2mg/kg, maintenance dose: 0.35mg/kg/h, |
| Propofol | Active comparator | Drug: PropofolFirst-stage: 5mg/kg/h, 2mg/kg/h; Second-stage:Single load ing dose: 1mg/kg, maintenance dose: 1.75mg/kg/h |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males or females with full capacity for civil conduct, aged ≥ 18 and ≤ 49 years old;
- Body weight > 45 kg, and body mass index (BMI) ≥ 19 and ≤26 kg/m2;
- Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 °C; respiration rate between 12-20 breaths per minute; SpO2 when inhaling > 95%;
- Normal physical examinations, laboratory examinations (routine blood test, blood biochemistry and routine urinalysis), and 12-Lead ECG, or abnormal but without clinical significance; no potential difficult airway (modified Mallampati score I-III);
- No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; No history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
Key exclusion criteria (21 listed)
- Known sensitivity to propofol, excipients in propofol medium-/long-chain triglyceride emulsion injection, excipients in HSK3486 emulsion injection (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); history of drug allergies (including anesthetics), allergic diseases, or those with hyperactive immune response;
- History of drug abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine drug test during screening;
- Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year;
- Serious infection, trauma or major surgery within 4 weeks before screening; or acute disease with clinical significance (determined by the investigator) within 2 weeks before screening, including GI diseases or infections (such as respiratory or CNS infections);
- In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 3 days prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK3486First-stage:after an initial dose of 1mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h. Second-stage: a single loading dose of 0.2 mg/kg given over 1 minute, then a continuous infusion of maintenance dose 0.35 mg/kg/h for a total infusion time of 12h. | Drug | HSK3486 |
| PropofolFirst-stage: after an initial dose of 5mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h. Second-stage: loading dose of 1mg/kg given over 1 minute, then a continuous infusion of maintenance dose 1.75 mg/kg/h for a total infusion time of 12h. | Drug | Propofol |
Primary outcome
blood pressure（systolic, diastolic and mean arterial pressure）
Time frame: from the screening to 3 days post-dose
safety endpoits
heart rate
Time frame: from the screening to 3 days post-dose
safety endpoits
respiratory rate
Time frame: from the screening to 3 days post-dose
safety endpoits
blood oxygen saturation
Time frame: from the screening to 3 days post-dose
safety endpoits
Number of patients with adverse events
Time frame: from the baseline to 3 days post-dose
safety endpoits
7 secondary outcomes
Richmond Agitation Sedation Scale( scores：+4~-5)
Time frame: -30 minutes before administration until the subject is completely awakened post administration on day 1
Bispectral index
Time frame: -30 minutes before administration until the subject is completely awakened post administration on day 1
Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
Time frame: -30 minutes before administration until the subject is completely awakened post administration on day 1
Terminal elimination half life
Time frame: -30 minutes before administration until 24 hours post administration on day 1
Total clearance
Time frame: -30 minutes before administration until 24 hours post administration on day 1
Volume of distribution
Time frame: -30 minutes before administration until 24 hours post administration on day 1
plasma concentration at the end of infusion
Time frame: -30 minutes before administration until 24 hours post administration on day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK3486 and Propofol in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure（systolic, diastolic and mean arterial pressure） (time frame: from the screening to 3 days post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.