AnesthesiaPhase 1NCT04033939
A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.
A Phase 1 study testing HSK3486 and Propofol in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd.
Trial summary
This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection. 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?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2014to 4 May 2015
- 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
- Male, aged 18 - 49 years (inclusive).
- In general good health without clinically significant (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-clinically significant (NCS) findings on a physical examination, 12-lead electrocardiogram (ECG) and vital signs (respiration rate between 12 and 20 breaths per minute, blood pressure 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).
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- Clinical laboratory values within the normal limits as defined by the clinical laboratory samples, unless the Principal Investigator (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.
Who cannot join
- 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.
- Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of simple analgesics such as paracetamol and oral non-steroidal antiinflammatory agents.
- Standard donation of blood within 30 days of the study.
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- 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.
- Clinically significant (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.
About this study
Official title: A Phase I, Placebo and Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Injection of HSK3486 in Healthy Subjects
This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection.
Results from this study will supports further clinical development of HSK3486. This study will be performed in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study concerned with the investigational product will meet the requirements of Good Manufacturing Practice (GMP).
- Conditions
- Anesthesia, Sedation
- Being tested
- HSK3486, Propofol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
PropofolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HSK3486-01 | Experimental | Randomized to receive HSK3486 (0.016mg/kg,0.064mg/kg )as a single IV injection. HSK3486-01 was blinded.(2 HSK3486-01: 1 Placebo-01) Receives: Drug: HSK3486 |
| Placebo-01 | Placebo comparator | Randomized to receive placebo (0.016mg/kg,0.064mg/kg )as a single IV injection. placebo-01 was blinded.(2 HSK3486-01: 1 Placebo-01) Receives: Drug: Placebo |
| HSK3486-02 | Experimental | Randomized to receive either HSK3486（0.128mg/kg,0.192mg/kg,0.288mg/kg,0.432mg/kg,0.540mg/kg,0.648mg/kg,0.810mg/kg) as a single IV injection. HSK3486-02 was open-label.(5 HSK3486-02: 1 propofol-02) Receives: Drug: HSK3486 |
| Propofol-02 | Active comparator | Randomized to receive propofol (2.5mg/kg) as a single IV injection. Propofol-02 was open-label.(5 HSK3486-02: 1 propofol-02) Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety by measurement of Adverse Events
Measured: First dose of study drug on day 1
Secondary outcomes (7)
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 posted26 Jul 2019
- Study start13 Apr 2014
- Primary completion11 Nov 2014
- Study completion4 May 2015
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT04033939
- Sponsor's protocol ID
- HSK3486Australia-01
- Status last verified
- Jun 2019
- First submitted
- 4 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Placebo and Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Injection of HSK3486 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04033939
- Acronym / sponsor ID
- HSK3486Australia-01
- Conditions
- Anesthesia, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2014 (actual)
- Primary completion
- 11 Nov 2014 (actual)
- Study completion
- 4 May 2015 (actual)
- First posted
- 26 Jul 2019 (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 the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection.
Results from this study will supports further clinical development of HSK3486. This study will be performed in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study concerned with the investigational product will meet the requirements of Good Manufacturing Practice (GMP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK3486-01 | Experimental | Drug: HSK3486Randomized to receive HSK3486 (0.016mg/kg,0.064mg/kg )as a single IV injection. HSK3486-01 was blinded.(2 HSK3486-01: 1 Placebo-01) |
| Placebo-01 | Placebo comparator | Drug: PlaceboRandomized to receive placebo (0.016mg/kg,0.064mg/kg )as a single IV injection. placebo-01 was blinded.(2 HSK3486-01: 1 Placebo-01) |
| HSK3486-02 | Experimental | Drug: HSK3486Randomized to receive either HSK3486（0.128mg/kg,0.192mg/kg,0.288mg/kg,0.432mg/kg,0.540mg/kg,0.648mg/kg,0.810mg/kg) as a single IV injection. HSK3486-02 was open-label.(5 HSK3486-02: 1 propofol-02) |
| Propofol-02 | Active comparator | Drug: PropofolRandomized to receive propofol (2.5mg/kg) as a single IV injection. Propofol-02 was open-label.(5 HSK3486-02: 1 propofol-02) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male, aged 18 - 49 years (inclusive).
- In general good health without clinically significant (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.
Key exclusion criteria (12 listed)
- 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.
- Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of simple analgesics such as paracetamol and oral non-steroidal antiinflammatory agents.
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 |
|---|---|---|
| HSK3486 | Drug | HSK3486-01, HSK3486-02 |
| Propofol | Drug | Propofol-02 |
| Placebo | Drug | Placebo-01 |
Primary outcome
Safety by measurement of Adverse Events
Time frame: First dose of study drug on day 1
7 secondary outcomes
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 26 Jul 2019.
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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 and Propofol 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 10 inclusion and 12 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 26 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Safety by measurement of Adverse Events (time frame: First dose of study drug on day 1). 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 26 Jul 2019.