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AnesthesiaPhase 1NCT04037657

Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects.

A Phase 1 study testing HSK3486 and Propofol 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 positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
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
25 participants
Where
No sites listed yet
Study dates
22 Apr 2015to 13 Nov 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
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female, aged 18 - 49 years (inclusive)
  • Women of child-bearing potential agreed to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
  • Negative serum pregnancy test
  • In general good health without 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)
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  • 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-CS findings on a physical examination, 12-lead Electrocardiogram (ECG) and vital signs (respiratory 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)
  • Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the 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 CONFIDENTIAL HSK3486 SAD_02 Sichuan Haisco Pharmaceutical Co., Ltd Version: 13 Nov 2015 Page 19 of 513
  • 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 anti-inflammatory 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 PI and Sponsor.
  • 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
  • CS (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
  • History of posture-related gastric reflux more than twice weekly
  • History of seizures or epilepsy
  • History of ischaemic heart disease
  • History of brady- or tachy-dysrhythmias requiring medical care
  • History of asthma, with bronchospasm requiring treatment in the last 3 months
  • 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.

About this study

Official title: A Phase 1b, Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Dose of HSK3486 in Healthy Female Subjects.

This study was a single-center positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Intensive safety, PD and PK assessments were performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

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

    HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).

  • PropofolDrug

    Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump.

Study groups in NCT04037657
Study groupRoleWhat they receive
HSK3486Experimental0.288 mg/kg ，0.432 mg/kg ，0.540 mg/kg ，0.648 mg/kg，0.810 mg/kg There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).
Receives: Drug: HSK3486
PropofolActive comparator2.5 mg propofol
Receives: Drug: Propofol

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: First dose of study drug on day 1

  2. Bispectral index （BIS）

    Measured: From first dose of study drug until fully alert on day 1

  3. 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: Time Frame: From first dose of study drug until fully alert on day 1

Secondary outcomes (5)

  1. Median effective dose (ED50)

    Measured: From first dose of study drug until fully alert on day 1

  2. Peak concentration (Cmax)

    Measured: From the start of administration to 48 hours after administration

  3. Time to plasma peak concentration(Tmax)

    Measured: From the start of administration to 48 hours after administration

  4. Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)

    Measured: From the start of administration to 48 hours after administration

  5. 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.

  1. First posted30 Jul 2019
  2. Study start22 Apr 2015
  3. Primary completion9 Jun 2015
  4. Study completion13 Nov 2015

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04037657
Sponsor's protocol ID
HSK3486-Australian-02
Status last verified
Dec 2015
First submitted
20 Jul 2019
Last updated
31 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 12 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 31 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. 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). The study lists 3 primary outcomes in all. 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 NCT04037657.

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 31 Jul 2019.

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