AnesthesiaPhase 1NCT03773835
A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
A Phase 1 study testing HSK3486 in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd.
Trial summary
his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Aug 2016
- 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, between 18 and 49 years old (inclusive);
- Body weight > 45 kg, and body mass index (BMI) ≥ 19 and ≤24 kg/m2;
- Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 ºC; respiration rate between 12-24 breaths per minute; SpO2 when inhaling > 95%;
- Normal physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), 12-Led ECG, posteroanterior and lateral chest x-ray, and or abnormal but without clinical significance (determined by investigator); no potential difficult airway;
- 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 clinical trial protocol.
Who cannot join
- Known sensitivity to propofol, excipient in propofol medium and long chain fat emulsion injection, excipient in HSK3486 injectable emulsion;
- contraindicated in general anesthesia;
- Received any one of the following medications or treatments prior to screening/enrollment:
- History of medication abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine medication test (during screening or at baseline);
- Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or participated in 3 or more drug clinical trials within the past year;
- History or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period;
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- Laboratory results that meet any of the following during screening/enrollment:
- Positive for HBsAg, HCV, or HIV;
- Abnormal hepatic or renal function confirmed after re-examination;
- ALT or AST > ULN;
- Creatinine > ULN;
- History of smoking for more than 3 weeks and/or respiratory irritation caused by smoking within 3 months prior to screening;
- History of alcohol abuse within 3 months prior to screening or a positive alcohol test (baseline);
- Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial;
- Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
About this study
Official title: A Single-center, Open-label, Uncontrolled, and Dose-escalation Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.
- Conditions
- Anesthesia, Sedation
- Being tested
- HSK3486
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
Mmanual IV bolus injection completed in 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | 0.15mg/kg, 0.40mg/kg, 0.60mg/kg, 0.90mg/kg, Receives: Drug: HSK3486 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea
No movement of chest wall and cessation of end-tidal carbon dioxide waveform > 15 seconds.
Measured: First dose of study drug on day 1
Safety by measurement of Adverse Events
Measured: First dose of study drug on day 1
Secondary outcomes (9)
Modified observer's assessment of alertness/sedation（MOAA/S）
Observe the change of modified observer's assessment of alert /sedation during the whole trial
Measured: From first dose of study drug until fully alert on day 1
Bispectral index （BIS）
Measured: From first dose of study drug until fully alert on day 1
Median effective dose (ED50)
Measured: From first dose of study drug until fully alert on day 1
Peak concentration (Cmax)
Measured: From the start of administration to 48 hours after administration
Time to plasma peak concentration(Tmax)
Measured: From the start of administration to 48 hours after administration
Terminal elimination half life (t1/2z) and mean residence time (MRT)
Measured: From the start of administration to 48 hours after administration
Mean residence time (MRT)
Measured: From the start of administration to 48 hours after administration
Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)
Measured: From the start of administration to 48 hours after administration
Total clearance (CL)
Measured: From the start of administration to 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study startMay 2016
- Primary completionAug 2016
- Study completionAug 2016
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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT03773835
- Sponsor's protocol ID
- HSK3486-101
- Status last verified
- Aug 2016
- First submitted
- 6 Dec 2018
- Last updated
- 3 Mar 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 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Uncontrolled, and Dose-escalation Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03773835
- Acronym / sponsor ID
- HSK3486-101
- Conditions
- Anesthesia, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Dec 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.
his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK34860.15mg/kg, 0.40mg/kg, 0.60mg/kg, 0.90mg/kg, |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males or females with full capacity for civil conduct, between 18 and 49 years old (inclusive);
- Body weight > 45 kg, and body mass index (BMI) ≥ 19 and ≤24 kg/m2;
- Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 ºC; respiration rate between 12-24 breaths per minute; SpO2 when inhaling > 95%;
- Normal physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), 12-Led ECG, posteroanterior and lateral chest x-ray, and or abnormal but without clinical significance (determined by investigator); no potential difficult airway;
- 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 clinical trial protocol.
Key exclusion criteria (15 listed)
- Known sensitivity to propofol, excipient in propofol medium and long chain fat emulsion injection, excipient in HSK3486 injectable emulsion;
- contraindicated in general anesthesia;
- Received any one of the following medications or treatments prior to screening/enrollment:
- History or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period;
- Laboratory results that meet any of the following during screening/enrollment:
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 |
|---|---|---|
| HSK3486Mmanual IV bolus injection completed in 1 minute. | Drug | HSK3486 |
Primary outcome
Apnea
Time frame: First dose of study drug on day 1
No movement of chest wall and cessation of end-tidal carbon dioxide waveform > 15 seconds.
Safety by measurement of Adverse Events
Time frame: First dose of study drug on day 1
9 secondary outcomes
Modified observer's assessment of alertness/sedation（MOAA/S）
Time frame: From first dose of study drug until fully alert on day 1
Bispectral index （BIS）
Time frame: From first dose of study drug until fully alert on day 1
Median effective dose (ED50)
Time frame: From first dose of study drug until fully alert on day 1
Peak concentration (Cmax)
Time frame: From the start of administration to 48 hours after administration
Time to plasma peak concentration(Tmax)
Time frame: From the start of administration to 48 hours after administration
Terminal elimination half life (t1/2z) and mean residence time (MRT)
Time frame: From the start of administration to 48 hours after administration
Mean residence time (MRT)
Time frame: From the start of administration to 48 hours after administration
Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)
Time frame: From the start of administration to 48 hours after administration
Total clearance (CL)
Time frame: From the start of administration to 48 hours after administration
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 3 Mar 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK3486 in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd.
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 5 inclusion and 15 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Apnea (time frame: First dose of study drug on day 1). The study lists 2 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 3 Mar 2020.