AnesthesiaPhase 1NCT04145583
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets
A Phase 1 study testing HSK3486 and voriconazole +HSK3486 in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This is a single-center, open-label, randomized, two-stage, two-way crossover study evaluating the effect of voriconazole on the PK, PD, and safety of HSK3486 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Sedation
- What is being tested?
- HSK3486 and voriconazole +HSK3486
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2019to 9 May 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females with full capacity for civil conduct, aged ≥18 and ≤45 years old. Both male and female subjects should be enrolled;
- Male subjects should weigh ≥50 kg, female subjects should weigh ≥45 kg, and the body mass index (BMI) should be ≥19.0 and ≤26.0 kg/m2;
- Blood pressure should be between 100-140/60-90 mmHg; heart rate should be between 60-99 bpm; body temperature (ear temperature) should be between 35.5-37.1°C; respiration rate should be between 12-20 breaths per minute; SpO2 when inhaling should be ≥95%;
- Normal results for physical examinations, laboratory tests (blood routine, blood biochemistry, urine routine, and blood coagulation routine), 12-lead electrocardiogram (ECG), chest X-ray, and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney), or abnormal results without clinical significance as judged by the investigator; no significantly potential difficult airway (modified Mallampati score I-II);
- No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, metabolic, and cardiovascular diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with the clinical trial protocol.
Who cannot join
- Known allergy to excipients in HSK3486 injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide) or voriconazole, or contraindications mentioned in the prescribing information of voriconazole ;
- In receipt of any one of the following medications or treatments during screening/baseline:
- History of drug abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine drug test during baseline; Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year; In receipt of voriconazole within 4 weeks prior to screening; In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 1 week prior to baseline; In receipt of prescription drugs, Chinese herbal medicines, over-the-counter drugs or food supplements (such as vitamins and calcium supplements) other than contraceptives, paracetamol, oral non-steroidal anti-inflammatory drugs, topical over-the-counter preparations, within 2 weeks prior to baseline; in receipt of strong inhibitors/inducers of CYP enzyme within 7 days prior to baseline, or in receipt of moderate/weak inhibitors/inducers of CYP enzyme within 3 days prior to baseline (see Attachment 4 for the inhibitors and inducers); unless the principal investigator (PI) and the sponsor agree that the medication has no effect on the safety and PK/PD results of the trial.
- A history or evidence of any one of the following diseases prior to screening/baseline:
- History of cardiovascular diseases such as: Uncontrolled hypertension [SBP ≥170 mmHg and/or DBP ≥105 mmHg without antihypertensive treatment, or SBP >160 mmHg and/or DBP >100 mmHg despite antihypertensive treatment], postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers), or QTcF interval ≥450 ms (Fridericia's correction formula); Respiratory insufficiency, history of obstructive pulmonary disease, history of asthma, sleep apnea; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infection, and with obvious symptoms such as fever, wheezing, nasal congestion, or cough within 1 week prior to baseline; History of GI tract diseases: Gastrointestinal obstruction, active GI bleed, potential for reflux and aspiration; Serious infection, trauma, or major surgery within 4 weeks before screening; or acute disease with clinical significance (determined by the investigator) within 2 weeks before screening, including GI diseases or infections (such as respiratory or CNS infections); History of eye diseases: Including glaucoma history and/or family history, history and/or family history of optic nerve diseases, subjects with proliferative diabetic retinopathy, history of intraocular surgery (cataract, retina, glaucoma), history of amblyopia, history of high myopia (≥8.0 D).
- Laboratory results that meet any of the following during screening/baseline:
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- Positive result for either HBsAg, HCV, HIV, or syphilis; Abnormality in any of the following indicators of hepatic and renal functions: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1 x ULN; creatinine > 1 x ULN; total bilirubin TBIL > 1 x ULN;
- History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with40% alcohol or 150 mL wine), or positive result for breath alcohol test (≥20 mg/dl);
- Smoke more than 5 cigarettes per day and a total of more than 60 cigarettes within 3 months prior to screening;
- Blood donation or blood loss ≥200 mL within 30 days prior to screening; plasma donation or plasma exchange within 7 days prior to screening;
- Subjects who consume any beverages or food containing alcohol, grapefruit juice or methylxanthine (such as coffee, tea, coca-cola, chocolate, functional drinks), participate in strenuous physical activities and other factors that may affect drug absorption, distribution, metabolism, and excretion within 2 days prior to enrollment; subjects who are unable to fast for 8 h prior to dose administration;
- Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Randomized, Two-Stage, and Two-Way Crossover Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets in Healthy Subjects
This is a single-center, open-label, randomized, two-stage, two-way crossover study evaluating the effect of voriconazole on the PK, PD, and safety of HSK3486 in healthy subjects.
Read the detailed description
After the recruited healthy subjects passed the screening of inclusion and exclusion criteria, a seed number was set in the PLAN program of the SAS 9.4 software by the statistician before the formal enrollment, and the subject screening numbers were randomly assigned to the two groups by using a 1:1 block randomization method. The enrolled subjects were assigned a subject number according to the results of randomization and received stage I dosing of HSK3486 injectable emulsion (sequence 1) or HSK3486 injectable emulsion + voriconazole (sequence 2). After a 7-day (sequence 1) or 14-day washout period (sequence 2), the stage II dosing of HSK3486 injectable emulsion + voriconazole (sequence 2) or HSK3486 injectable emulsion (sequence 1) was carried out in a crossover fashion.
- Conditions
- Anesthesia, Sedation
- Being tested
- HSK3486, voriconazole +HSK3486
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
voriconazole +HSK3486Drug
Sequence 2: voriconazole：Day 1,400mg，BID；Day 2--Day 6,200mg，BID；200 mg of voriconazole were taken orally in the morning on an empty stomach of Day 7; followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | 0.4 mg/kg Receives: Drug: HSK3486 |
| voriconazole , HSK3486 | Experimental | 400 or 200 mg; 0.4 mg/kg Receives: Drug: voriconazole +HSK3486 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Measured: From the start of HSK3486 administration to 24 hours after the start of administration on day 1
Area under the concentration-time curve (AUC0-t, AUC0-∞)
Measured: From the start of HSK3486 administration to 24 hours after the start of administration on day 1]
Secondary outcomes (1)
Terminal elimination half-life (t1/2)
Measured: From the start of HSK3486 administration to 24 hours after the start of administration on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start14 Dec 2019
- Primary completion6 Jan 2020
- Study completion9 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, PhD, Study director, Medical Ethics Committee of the First Affiliated Hospital of soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145583
- Sponsor's protocol ID
- HSK3486-107
- Status last verified
- Dec 2020
- First submitted
- 25 Oct 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bian Y, Hu T, Deng Q, Ma S, Jiao Y, Shi J, Jiang N, Hu M, Wang Y, Liu X, Zhang Z, Huang C, Zhang H, Miao L. Effects of Voriconazole on the Safety, Pharmacokinetics and Pharmacodynamics of Ciprofol (HSK3486), a Novel Intravenous Anaesthetic, in Healthy Participants: A Prospective, Randomized, Crossover Clinical Trial. Drug Des Devel Ther. 2026 Jan 8;20:562125. doi: 10.2147/DDDT.S562125. eCollection 2026.
PubMed 41836529
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized, Two-Stage, and Two-Way Crossover Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04145583
- Acronym / sponsor ID
- HSK3486-107
- Conditions
- Anesthesia, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 9 May 2020 (actual)
- First posted
- 30 Oct 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 a single-center, open-label, randomized, two-stage, two-way crossover study evaluating the effect of voriconazole on the PK, PD, and safety of HSK3486 in healthy subjects.
Detailed description
After the recruited healthy subjects passed the screening of inclusion and exclusion criteria, a seed number was set in the PLAN program of the SAS 9.4 software by the statistician before the formal enrollment, and the subject screening numbers were randomly assigned to the two groups by using a 1:1 block randomization method. The enrolled subjects were assigned a subject number according to the results of randomization and received stage I dosing of HSK3486 injectable emulsion (sequence 1) or HSK3486 injectable emulsion + voriconazole (sequence 2). After a 7-day (sequence 1) or 14-day washout period (sequence 2), the stage II dosing of HSK3486 injectable emulsion + voriconazole (sequence 2) or HSK3486 injectable emulsion (sequence 1) was carried out in a crossover fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK34860.4 mg/kg |
| voriconazole , HSK3486 | Experimental | Drug: voriconazole +HSK3486400 or 200 mg; 0.4 mg/kg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males or females with full capacity for civil conduct, aged ≥18 and ≤45 years old. Both male and female subjects should be enrolled;
- Male subjects should weigh ≥50 kg, female subjects should weigh ≥45 kg, and the body mass index (BMI) should be ≥19.0 and ≤26.0 kg/m2;
- Blood pressure should be between 100-140/60-90 mmHg; heart rate should be between 60-99 bpm; body temperature (ear temperature) should be between 35.5-37.1°C; respiration rate should be between 12-20 breaths per minute; SpO2 when inhaling should be ≥95%;
- Normal results for physical examinations, laboratory tests (blood routine, blood biochemistry, urine routine, and blood coagulation routine), 12-lead electrocardiogram (ECG), chest X-ray, and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney), or abnormal results without clinical significance as judged by the investigator; no significantly potential difficult airway (modified Mallampati score I-II);
- No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, metabolic, and cardiovascular diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
Key exclusion criteria (12 listed)
- Known allergy to excipients in HSK3486 injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide) or voriconazole, or contraindications mentioned in the prescribing information of voriconazole ;
- In receipt of any one of the following medications or treatments during screening/baseline:
- History of drug abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine drug test during baseline; Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year; In receipt of voriconazole within 4 weeks prior to screening; In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 1 week prior to baseline; In receipt of prescription drugs, Chinese herbal medicines, over-the-counter drugs or food supplements (such as vitamins and calcium supplements) other than contraceptives, paracetamol, oral non-steroidal anti-inflammatory drugs, topical over-the-counter preparations, within 2 weeks prior to baseline; in receipt of strong inhibitors/inducers of CYP enzyme within 7 days prior to baseline, or in receipt of moderate/weak inhibitors/inducers of CYP enzyme within 3 days prior to baseline (see Attachment 4 for the inhibitors and inducers); unless the principal investigator (PI) and the sponsor agree that the medication has no effect on the safety and PK/PD results of the trial.
- A history or evidence of any one of the following diseases prior to screening/baseline:
- History of cardiovascular diseases such as: Uncontrolled hypertension [SBP ≥170 mmHg and/or DBP ≥105 mmHg without antihypertensive treatment, or SBP >160 mmHg and/or DBP >100 mmHg despite antihypertensive treatment], postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers), or QTcF interval ≥450 ms (Fridericia's correction formula); Respiratory insufficiency, history of obstructive pulmonary disease, history of asthma, sleep apnea; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infection, and with obvious symptoms such as fever, wheezing, nasal congestion, or cough within 1 week prior to baseline; History of GI tract diseases: Gastrointestinal obstruction, active GI bleed, potential for reflux and aspiration; Serious infection, trauma, or major surgery within 4 weeks before screening; or acute disease with clinical significance (determined by the investigator) within 2 weeks before screening, including GI diseases or infections (such as respiratory or CNS infections); History of eye diseases: Including glaucoma history and/or family history, history and/or family history of optic nerve diseases, subjects with proliferative diabetic retinopathy, history of intraocular surgery (cataract, retina, glaucoma), history of amblyopia, history of high myopia (≥8.0 D).
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 |
|---|---|---|
| HSK3486Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min. | Drug | HSK3486 |
| voriconazole +HSK3486Sequence 2: voriconazole：Day 1,400mg，BID；Day 2--Day 6,200mg，BID；200 mg of voriconazole were taken orally in the morning on an empty stomach of Day 7; followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later. | Drug | voriconazole , HSK3486 |
Primary outcome
Peak concentration (Cmax)
Time frame: From the start of HSK3486 administration to 24 hours after the start of administration on day 1
Area under the concentration-time curve (AUC0-t, AUC0-∞)
Time frame: From the start of HSK3486 administration to 24 hours after the start of administration on day 1]
1 secondary outcome
Terminal elimination half-life (t1/2)
Time frame: From the start of HSK3486 administration to 24 hours after the start of administration on day 1
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 19 Dec 2020.
- Derived from this study: PubMed 41836529Bian Y, Hu T, Deng Q, Ma S, Jiao Y, Shi J, Jiang N, Hu M, Wang Y, Liu X, Zhang Z, Huang C, Zhang H, Miao L. Effects of Voriconazole on the Safety, Pharmacokinetics and Pharmacodynamics of Ciprofol (HSK3486), a Novel Intravenous Anaesthetic, in Healthy Participants: A Prospective, Randomized, Crossover Clinical Trial. Drug Des Devel Ther. 2026 Jan 8;20:562125. doi: 10.2147/DDDT.S562125. eCollection 2026.
- 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.
Liyan Miao, PhD study director
Medical Ethics Committee of the First Affiliated Hospital of soochow University
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 voriconazole +HSK3486 in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
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 6 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 19 Dec 2020. 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 China. 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. 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?
Peak concentration (Cmax) (time frame: From the start of HSK3486 administration to 24 hours after the start of administration on day 1). 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?
On the ClinicalTrials.gov record for NCT04145583, which also lists 1 linked publication.
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 19 Dec 2020.