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General AnestheticPhase 1NCT04054063

A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects

A Phase 1 study testing HSK3486+ etomidate in people with General Anesthetic 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 is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety profile including pain on injection, hypotension, tachycardia or bradycardia effects… 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
General Anesthetic, Sedation
What is being tested?
HSK3486+ etomidate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
30 Nov 2016to 28 Jun 2017
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, as determined by the investigator
  • 3.American Society of Anesthesiologists 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, hepatitis C 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 ECG and vital signs (respiration rate between 12 and 20 breaths per minute, BP between 100-140/50-90 mmHg, heart rate between 45-99 beats per minute, temperature between 35.8 degrees and 37.5 degrees). 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 decides that out-of-range values are 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, etomidate or components of 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 anesthesia induction
  • 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 4 standard drinks daily, on average) or use of recreational drugs within the last 3 months prior to screening
  • 5.Intake of > 8 caffeine-containing drinks per day, on average, or approximately 800mg of caffenine daily on average; history of intolerance of abstinencce from caffeine for 3 days
  • 6.Use of prescription or over the counter medications within 7 days of investigational product administration, with the exception of paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed the recommended daily dose), unless agreed as non-clinically relevant by the investigator and sponsor.
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  • 7.Standard donation of blood within 30 days of the study
  • 8.Donation of plasma or participation in a plasmapheresis program within 7 days of investigational product administration
  • 9.Receipt of any investigational study drug within 30 days prior to screening
  • 10.Unable to fast for the 6 hours prior to investigational product administration
  • 11.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
  • 12.Anticipated need for surgery or hospitalization during the study
  • 13.Craniofacial abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia
  • 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, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study
  • 19.Receipt of HSK3486 less than 4 weeks prior to the start of the study.

About this study

Official title: An Open Label, Single-Center, Single Dose Combination of HSK3486 and Etomidate Intravenous Bolus Injection to Determine the Safety, Pharmacodynamics and Pharmacokinetics for Induction of Anesthesia in Healthy Male Subjects

This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety profile including pain on injection, hypotension, tachycardia or bradycardia effects (HSK3486), and involuntary muscle movements, nausea and vomiting potential and adrenal suppression (etomidate).

All subjects will be administered HSK3486 plus etomidate. Subjects will be confined to the study unit from the evening of Day -1 until the morning of Day 2, then will be required to return for a follow up visit on Day 7.

Intensive PD, PK, safety and tolerability and assessments will be performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

Being tested
HSK3486+ etomidate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK3486+ etomidateDrug

Study groups in NCT04054063
Study groupRoleWhat they receive
HSK3486+etomidateExperimentalCohort 1: HSK3486 0.324 mg/kg + etomidate 0.15 mg/kg Cohort 2: HSK3486 0.216 mg/kg + etomidate 0.2 mg/kg Cohort 3: HSK3486 0.432 mg/kg + etomidate 0.1 mg/kg There were an additional 2 cohorts (Cohorts 4 and 5) planned for dose escalation once the optimal ratio of the drug combination was identified from the first 3 cohorts. However, these 2 cohorts were not done as the results of Cohorts 1 to 3 suggested that dose increases would cause higher occurrence of drug-related adverse events (AEs).
Receives: Drug: HSK3486+ etomidate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety by measurement of Adverse Events

    Measured: on day 1 until 24 hours post-dose

Secondary outcomes (6)

  1. Richmond Agitation Sedation Scale (RASS)

    • 0 Alert and calm
    • 1 Not fully alert, but has sustained awakening (eyeopening/eye contact) to voice (≥ 10 seconds)
    • 2 Briefly awakens with contact to voice (< 10 seconds)
    • 3 Movement or eye opening to voice (but no eye contact)
    • 4 No response to voice, but movement or eye opening to physical stimulation
    • 5 No response to voice or physical stimulation

    Measured: First dose of study drug on day 1

  2. bispectral index (BIS)

    Measured: First dose of study drug on day 1

  3. subject-rated Quality of Recovery Assessment (QoR-9）

    Measured: First dose of study drug on day 1

  4. Peak concentration (Cmax)

    Measured: on day 1 until 24 hours post-dose

  5. Time to plasma peak concentration(Tmax)

    Measured: on day 1 until 24 hours post-dose

  6. Area Under the Curve

    Measured: on day 1 until 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start30 Nov 2016
  3. Primary completion21 Dec 2016
  4. Study completion28 Jun 2017

Resources

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
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04054063
Sponsor's protocol ID
HSK3486-Australian-04
Status last verified
Jun 2017
First submitted
4 Jul 2019
Last updated
13 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK3486+ etomidate in people with General Anesthetic 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 19 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 13 Aug 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. 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: on day 1 until 24 hours post-dose). 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 NCT04054063.

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 13 Aug 2019.

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