General AnesthesiaPhase 1NCT05614544
Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
A Phase 1 study testing HSK3486 and Propofol in people with General Anesthesia, run by Haisco-USA Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Part 1: To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study. Part 2: To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy nondependent, recreational CNS depressant drug users. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 3 Oct 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to participate in the study, give written informed consent, and comply with the study restrictions.
- Gender: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: 18 years to 55 years, inclusive, at Screening.
- Body mass index (BMI): 18.0 kg/m2 to 30.0 kg/m2, inclusive.
- Weight: ≥50 kg, inclusive.
- Healthy subject, defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.
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- Subject must be a nondependent, nontreatment-seeking recreational CNS depressant user, defined as follows:
- ≥10 lifetime nontherapeutic experiences (i.e., for psychoactive effects) with CNS depressants (e.g., benzodiazepines, barbiturates, opiates, zolpidem, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate).
- ≥1 nontherapeutic use of a CNS depressant within the 8 weeks prior to Screening.
- ≥1 nontherapeutic use of benzodiazepines within the 12 months prior to Screening.
- Ability and willingness to abstain from alcohol-, caffeine-, and xanthine-containing beverages or food (e.g., coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to first admission to the CRU, throughout the entire study, and until discharge.
- All values for hematology and clinical chemistry tests of blood and urine within the normal range or show no clinically relevant deviations, as judged by the Investigator.
- Females of childbearing potential, and males with female partner(s) of childbearing potential, as judged by the Investigator, must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom, cervical cap, and diaphragm. Acceptable non barrier forms of contraception for this study are an intrauterine device (IUD) including hormonal IUDs, oral contraceptives (used for ≥30 days prior to dosing any study treatment), and/or spermicide.
- For females: a negative pregnancy test at Screening and Admission.
- Postmenopausal females: defined as 12 months with no menses prior to Screening and a serum follicle stimulating hormone (FSH) >40 IU/L at Screening.
- All nonregular medication (including over-the-counter medication, health supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to (the first) admission to the CRU. An exception is made for acetaminophen, which is allowed up to admission to the CRU.
- All prescribed medication must have been stopped at least 30 days prior to (first) admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.
- Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
Who cannot join
- An employee of the Sponsor or research site personnel directly affiliated with this study or their immediate family member (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
- Drug or alcohol dependence within the 2 years prior to Screening (except nicotine and caffeine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM IV TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- Opioid dependence as judged by the Investigator after a naloxone challenge.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days of last study drug administration.
- Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days of last study drug administration.
- Positive drug and alcohol screen (tetrahydrocannabinol [THC], morphine/opiates, methadone, oxycodone, phencyclidine, cocaine, amphetamines, methamphetamines, ecstasy, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at each admission to the CRU. For THC, subjects should ideally test negative. However, eligibility decision with regards to THC use will be considered on a case by case basis, at the discretion of the Investigator.
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- Treatment with an investigational drug or device within 5 times the elimination half-life, if known (e.g., a marketed product) or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study. An exception may be made for subjects who participated in Part 1 of the study.
- History or presence of clinically significant abnormality (e.g., obstructive sleep apnea) as assessed by physical examination, medical history, ECG, vital signs, or laboratory values, which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects.
- Mallampati intubation score >2.
- History of clinically significant drug allergy diagnosed by a physician. Confirmatory circumstances would include treatment with epinephrine or in an emergency department.
- Any personal or family history of issues with succinylcholine, such as malignant hyperthermia or pseudocholinesterase deficiency.
- History of allergy, adverse reaction (including significant agitation, etc.), or hypersensitivity to propofol, lidocaine, other injected anesthetic agents, or related drugs.
- History of allergy to eggs, egg products, soybeans or soy products.
- Heavy smoker (>20 cigarettes per day) and/or is unable to abstain from smoking and/or the use of prohibited nicotine-containing products (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges) from 2 hours prior to dosing until at least 4 hours postdose during the in clinic periods.
- Routine or chronic use of more than 3000 mg of acetaminophen daily.
- Strenuous activity (such as exercise), sunbathing, and contact sports within 48 hours (2 days) prior to admission to the CRU, during the study, and until after discharge in the last study period.
- History of donation of more than 450 mL of blood within 60 days prior to dosing in the CRU or planned donation before 30 days has elapsed since last intake of study drug.
- Plasma or platelet donation within 7 days of dosing and throughout the entire study.
- Average intake of more than 14 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). Alcohol consumption will be prohibited 48 hours prior to first admission to the CRU and throughout the entire study until the Follow-up visit (including washout period).
- Positive screening test for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-HIV 1 and 2 antibodies.
- History of peripheral vasculopathy, including Raynaud's phenomenon.
- History of seizures, seizure disorder, or known electroencephalogram (EEG) abnormalities.
- History of mental illness, which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Subject with a history of clinically significant head injury, ongoing seizure disorder, chronic tics, or diagnosis or family history of Tourette's syndrome.
- Subjects with a history of serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, advanced arteriosclerosis, symptomatic cardiovascular disease, hypertension, or other cardiac problems.
- Any history of clinically significant suicidality as assessed by the Investigator based upon clinical history, source documents, or scores on the Columbia Suicide Severity Rating Scale (C-SSRS).
- History or presence of clinically significant hepatic or renal disease.
- History of hyperthyroidism.
- Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.
- Use of a cytochrome P450 (CYP)2D6-inhibiting drug or a serotonergic drug within 14 days prior to first drug administration in the Qualification Phase.
- Consumption of any nutrients known to modulate CYP enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 14 days prior to administration of study medication and during the study (including washout period) until after discharge in the last study period.
- A subject who, in the opinion of the Investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason.
- A subject who has pending legal charges or is on probation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-Part, Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
Part 1: To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study.
Part 2: To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy nondependent, recreational CNS depressant drug users.
Read the detailed description
This single center study will consist of 2 parts. Part 1 will be an open-label, dose-finding study of HSK3486 and propofol conducted in up to 48 recreational users of CNS depressants to determine the appropriate doses to be used in Part 2 of the study. Part 2 will be a randomized, double-blind, placebo- and active-controlled 4-period, 4 way crossover, in approximately 42 healthy volunteers with prior recreational CNS depressant exposure. Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit, an in-clinic Treatment Phase, and Follow-up; Part 2 will also include a Qualification Phase.
- Conditions
- General Anesthesia
- 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
HSK3486 for induction of general anesthesia
PropofolDrug
Propofol for induction of general anesthesia
PlaceboDrug
Intralipid
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: HSK3486 dose 1 | Experimental | Treatment A: HSK3486 dose 1 (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1) Receives: Drug: HSK3486 |
| Treatment B: HSK3486 dose 2 | Experimental | Treatment B: HSK3486 dose 2 (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1) Receives: Drug: HSK3486 |
| Treatment C: Propofol | Active comparator | Treatment C: Propofol (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1) Receives: Drug: Propofol |
| Treatment D: Placebo | Placebo comparator | Treatment D: Placebo (Treatment A matched) (IV bolus over 30 seconds [+5 seconds] from a syringe) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1
To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study
Measured: Screening between Day -28 and Day -5; confinement period 9 days in clinic from Day -4 (admission) to 24 hours after study drug administration in period 4; follow-up 3 to 7 days after study drug administration
Part 2
To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy nondependent, recreational CNS depressant drug users
Measured: Screening between Day -28 and Day -2; confinement period 2 days in clinic from Day -1 (admission) to 24 hours after study drug administration; follow-up 3 to 7 days after study drug administration
Secondary outcomes (2)
To evaluate the safety and tolerability of HSK3486 in healthy, nondependent, recreational CNS depressant drug users
To evaluate the safety and tolerability of HSK3486 in healthy, nondependent, recreational CNS depressant drug users
Measured: Screening between Day -28 and Day -5; confinement period 9 days in clinic from Day -4 (admission) to 24 hours after study drug administration in period 4; follow-up 3 to 7 days after study drug administration
• To evaluate the safety and tolerability of HSK3486 compared to propofol when administered IV to healthy nondependent, recreational CNS depressant drug users
- To evaluate the safety and tolerability of HSK3486 compared to propofol when administered IV to healthy nondependent, recreational CNS depressant drug users
- To evaluate the PK profile of HSK3486 when administered IV to healthy nondependent, recreational CNS depressant drug users
Measured: Screening between Day -28 and Day -2; confinement period 2 days in clinic from Day -1 (admission) to 24 hours after study drug administration; follow-up 3 to 7 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start16 Aug 2022
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614544
- Sponsor's protocol ID
- HSK3486-110
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part, Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
- ClinicalTrials.gov ID
- NCT05614544
- Acronym / sponsor ID
- HSK3486-110
- Conditions
- General Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 14 Nov 2022 (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.
Part 1: To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study.
Part 2: To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy nondependent, recreational CNS depressant drug users.
Detailed description
This single center study will consist of 2 parts. Part 1 will be an open-label, dose-finding study of HSK3486 and propofol conducted in up to 48 recreational users of CNS depressants to determine the appropriate doses to be used in Part 2 of the study. Part 2 will be a randomized, double-blind, placebo- and active-controlled 4-period, 4 way crossover, in approximately 42 healthy volunteers with prior recreational CNS depressant exposure. Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit, an in-clinic Treatment Phase, and Follow-up; Part 2 will also include a Qualification Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: HSK3486 dose 1 | Experimental | Drug: HSK3486Treatment A: HSK3486 dose 1 (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1) |
| Treatment B: HSK3486 dose 2 | Experimental | Drug: HSK3486Treatment B: HSK3486 dose 2 (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1) |
| Treatment C: Propofol | Active comparator | Drug: PropofolTreatment C: Propofol (IV bolus over 30 seconds [+5 seconds] from a syringe; dose to be determined in Part 1) |
| Treatment D: Placebo | Placebo comparator | Drug: PlaceboTreatment D: Placebo (Treatment A matched) (IV bolus over 30 seconds [+5 seconds] from a syringe) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Willing to participate in the study, give written informed consent, and comply with the study restrictions.
- Gender: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: 18 years to 55 years, inclusive, at Screening.
- Body mass index (BMI): 18.0 kg/m2 to 30.0 kg/m2, inclusive.
- Weight: ≥50 kg, inclusive.
Key exclusion criteria (34 listed)
- An employee of the Sponsor or research site personnel directly affiliated with this study or their immediate family member (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
- Drug or alcohol dependence within the 2 years prior to Screening (except nicotine and caffeine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM IV TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- Opioid dependence as judged by the Investigator after a naloxone challenge.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days of last study drug administration.
- Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days of last study drug administration.
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 |
|---|---|---|
| HSK3486HSK3486 for induction of general anesthesia | Drug | Treatment A: HSK3486 dose 1, Treatment B: HSK3486 dose 2 |
| PropofolPropofol for induction of general anesthesia | Drug | Treatment C: Propofol |
| PlaceboIntralipid | Drug | Treatment D: Placebo |
Primary outcome
Part 1
Time frame: Screening between Day -28 and Day -5; confinement period 9 days in clinic from Day -4 (admission) to 24 hours after study drug administration in period 4; follow-up 3 to 7 days after study drug administration
To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study
Part 2
Time frame: Screening between Day -28 and Day -2; confinement period 2 days in clinic from Day -1 (admission) to 24 hours after study drug administration; follow-up 3 to 7 days after study drug administration
To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy nondependent, recreational CNS depressant drug users
2 secondary outcomes
To evaluate the safety and tolerability of HSK3486 in healthy, nondependent, recreational CNS depressant drug users
Time frame: Screening between Day -28 and Day -5; confinement period 9 days in clinic from Day -4 (admission) to 24 hours after study drug administration in period 4; follow-up 3 to 7 days after study drug administration
• To evaluate the safety and tolerability of HSK3486 compared to propofol when administered IV to healthy nondependent, recreational CNS depressant drug users
Time frame: Screening between Day -28 and Day -2; confinement period 2 days in clinic from Day -1 (admission) to 24 hours after study drug administration; follow-up 3 to 7 days after study drug 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 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK3486 and Propofol in people with General Anesthesia, run by Haisco-USA Pharmaceuticals, Inc. at 1 site in United States.
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 18 inclusion and 34 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Part 1 (time frame: Screening between Day -28 and Day -5; confinement period 9 days in clinic from Day -4 (admission) to 24 hours after study drug administration in period 4; follow-up 3 to 7 days after study drug administration). 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 13 Oct 2023.