AnesthesiaPhase 1NCT04029766

A Study Evaluating Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 Single Bolus Dose Followed With a 30 Minute Constant Infusion in Healthy Male Subjects

A Phase 1 study testing HSK3486 in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was a single center, open-label, single dose escalation study in healthy male subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486 over two cohorts. Read more about this study

Who is it for?: Ages 18 to 49 years, men onlyHealthy 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: 13 participants
Where: No sites listed yet
Study dates: 10 Nov 2015to 9 Jun 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

1. Male, aged 18 - 49 years (inclusive);
2. Be in general good health without clinically significant medical history;
3. American Society of Anesthesiologists (ASA) Physical Status Classification of I or II;
4. Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive);
5. Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBs-Ag), hepatitis C (HCVAb) and Human Immunodeficiency Virus (HIV) at Screening; and drugs of abuse, alcohol pre dose on Day -1
6. Normal or non-clinically significant findings on a physical examination, 12-lead electrocardiogram (ECG) and vital signs (respiration 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.);

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7. Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Investigator decided that out-of-range values were not clinically significant;
8. Ability to provide written informed consent;
9. Willing and able to follow study instructions and likely to complete all study requirements;
10. Suitable venous and arterial access.

Who cannot join

1. 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;
2. History of clinically significant problems with general anesthesia;
3. Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to Screening;
4. History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months;
5. 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 antiinflammatory 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 Principal Investigator and Sponsor;
6. Standard donation of blood within 30 days of the study;

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7. Donation of plasma or participation in a plasmapheresis program within 7 days preceding this study;
8. Receipt of any investigational study drug within 30 days prior to Screening;
9. Unable to fast for the 6 hours prior to Investigational Product administration;
10. 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;
11. Anticipated need for surgery or hospitalization during the study;
12. Anatomical abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia;
13. History of posture-related gastric reflux more than twice weekly;
14. History of seizures or epilepsy ;
15. History of ischaemic heart disease;
16. History of brady- or tachy-dysrhythmias requiring medical care;
17. History of asthma, with bronchospasm requiring treatment in the last 3 months;
18. Any condition, which in the Investigator's opinion, put the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study.

About this study

Official title: A Phase 1 Study to Investigate a Single Bolus Dose Followed With a 30 Minute Constant Infusion of HSK3486 on the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 in Healthy Male Subjects.

This study was a single center, open-label, single dose escalation study in healthy male subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486 over two cohorts.

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

Study groups in NCT04029766
Study group	Role	What they receive
HSK3486	Experimental	0.288 mg/kg bolus (1 min)+ 1 mg/kg/h constant infusion (30 min) or 0.540 mg/kg bolus (1 min)+ 2 mg/kg/h constant infusion (30 min) Receives: Drug: HSK3486

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 (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.

10 Nov 20159 Jun 2016

First posted23 Jul 2019
Study start10 Nov 2015
Primary completion14 Dec 2015
Study completion9 Jun 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
Allocation: Not applicable
Intervention model: Single group
Model description: Single Group Assignment
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04029766
Sponsor's protocol ID: HSK3486Australia-03
Status last verified: Jun 2019
First submitted: 4 Jul 2019
Last updated: 29 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Investigate a Single Bolus Dose Followed With a 30 Minute Constant Infusion of HSK3486 on the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 in Healthy Male Subjects.
ClinicalTrials.gov ID: NCT04029766
Acronym / sponsor ID: HSK3486Australia-03
Conditions: Anesthesia, Sedation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
Study start: 10 Nov 2015 (actual)
Primary completion: 14 Dec 2015 (actual)
Study completion: 9 Jun 2016 (actual)
First posted: 23 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 study was a single center, open-label, single dose escalation study in healthy male subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486 over two cohorts.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group Assignment

Arm	Type	Receives
HSK3486	Experimental	Drug: HSK34860.288 mg/kg bolus (1 min)+ 1 mg/kg/h constant infusion (30 min) or 0.540 mg/kg bolus (1 min)+ 2 mg/kg/h constant infusion (30 min)

Who may qualify

Ages: 18 to 49 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

1. Male, aged 18 - 49 years (inclusive);
2. Be in general good health without clinically significant medical history;
3. American Society of Anesthesiologists (ASA) Physical Status Classification of I or II;
4. Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive);
5. Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBs-Ag), hepatitis C (HCVAb) and Human Immunodeficiency Virus (HIV) at Screening; and drugs of abuse, alcohol pre dose on Day -1

Key exclusion criteria (18 listed)

1. 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;
2. History of clinically significant problems with general anesthesia;
3. Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to Screening;
4. History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months;
5. 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 antiinflammatory 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 Principal Investigator and Sponsor;

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

Primary outcome

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 29 Jan 2021.

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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 10 inclusion and 18 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 29 Jan 2021. 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?

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?

On the ClinicalTrials.gov record for NCT04029766.

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 29 Jan 2021.