AnesthesiaPhase 1NCT03751969

A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults

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

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous [14C]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and provide a reference for reasonable use of this drug. 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: 0 participants
Where: No sites listed yet
Study dates: 30 Mar 2020to 1 Dec 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 49 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Subjects enrolled in this study are required to meet all of the following:
Healthy Chinese males aged 18-49 years old (inclusive);
Body weight: body mass index (BMI) between 19-26 kg/m2 (inclusive); weight should be no less than 50 kg; weight difference between the lightest and the heaviest subjects enrolled should be no more than 10 kg;
Vital signs: blood pressure between 90-140/60-90 mmHg; heart rate or pulse between 60-99 beats/min; body temperature (ear temperature) between 35.5-37.1 °C; respiratory rate between 12-24 breaths/min; blood oxygen saturation when inhaling ≥ 96% (inclusive);
Normal major organ function, e.g. routine blood test, blood biochemistry, routine urinalysis, feces and fecal occult blood test, and blood coagulation are all normal, or abnormal with no clinical significance as judged by the investigators;
Subjects who voluntarily sign the informed consent form, able to communicate well with the investigator and complete all trial procedures in accordance with the protocol.

Who cannot join

Subjects who meet any of the following will be excluded:
Subjects with clinically significant abnormalities during screening in physical examinations, laboratory tests, 12-lead ECG, chest X-ray or airway evaluation, including airway evaluation of a modified Mallampati score of IV; subjects with positive test result for hepatitis B surface antigen, hepatitis B e antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
Medication history: In receipt of any other investigational drug or participated in any drug or medical device clinical trial within 3 months before screening; or in receipt of propofol, other sedative/narcotic drugs and/or opioid analgesics or compounds containing analgesics within 72 hours prior to screening; or in receipt of any 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, and topical over-the-counter preparations within 2 weeks before screening; subjects can only be enrolled given the condition that the primary investigator (PI) and the sponsor agree that the drug used has no effect on the safety and mass balance results of the trial;
Past and current medical history:
A Subjects with a history of any severe disease, or concomitant diseases or abnormalities that may affect the test results as judged by the investigator, including but not limited to diseases or abnormalities in the circulatory system, endocrine system, neurological system, digestive system, urinary system, hematologic system, immune system, mental and metabolic aspects; B Subjects who have a past or current history of cardiovascular disease, including: heart failure, ischemic heart disease, long QT syndrome, arrhythmia requiring medication; a family history of Adams-Stokes syndrome or long QT syndrome; QTcF interval ≥ 450 ms (corrected by Fridericia's formula); C Subjects who have a past or current history of respiratory disease, including: obstructive pulmonary disease, asthma, or a history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infections within 1 week prior to screening, with significant fever, wheezing, nasal congestion, and coughing.
D Subjects who have a past or current history of gastrointestinal disease, including: gastroesophageal reflux, hemorrhoids or perianal disease with fecal blood, habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, etc.; E Subjects who have major surgery within 6 months before screening, or surgical incision not completely healed. Major surgery includes, but is not limited to any surgery that has a significant risk of bleeding, prolonged general anesthesia, incisional biopsy or significant traumatic injury; F Subjects with hyperactive immune response, including: sensitive to excipients of HSK3486 emulsion injections (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), history of drug allergies (including anesthetics), or other allergic diseases (such as allergic to any food ingredient or have special dietary requirements and cannot follow a uniform diet);

Show all 14Show fewer

Alcohol abuse or history of alcohol abuse within 3 months prior to screening, e.g. > 14 units of alcohol consumption per week (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive result for breath alcohol test at screening;
Consumption of more than 5 cigarettes daily within 3 months before screening or habitual use of nicotine-containing products which cannot be withdrawn during the trial; history of respiratory irritation symptoms caused by smoking;
Chronic drug abuse or use of soft drugs (such as marijuana) within 3 months before screening; or use of hard drugs (such as cocaine, amphetamines, phencyclidine) within 1 year before screening; or any signs of chronic benzodiazepines use (such as insomnia, anxiety) or positive urine drug test during screening;
Habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages which cannot be withdrawn during the trial;
Engaged in work requiring long-term exposure to radioactive conditions; or significant radioactive exposure within 1 year prior to the trial (≥ 2 chest/abdominal CT, or ≥ 3 other types of X-ray tests); or those who have participated in radiolabelling testing;
Fertility planner during the trial period and within 1 year after the completion of the trial, or subjects or their spouses who refuse to take strict contraceptive measures (including taking condom, contraceptive sponge, contraceptive gel, diaphragm, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) during the trial and within 1 year after the completion of the trial;
Subjects who received blood transfusion within 1 month before screening or who had blood loss or blood donation ≥ 200 mL, or subjects who had plasma donation or plasma exchange within 7 days before the trial;
Subject deemed unsuitable by the investigator for any other reason

About this study

Official title: A Study Evaluating the Mass Balance of Micro-dose [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults

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
The first 2 subjects will receive an intravenous injection of 0.4 mg/kg of HSK3486 emulsion injection (containing [14C] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg, i.e. a subject with the body weight of 60 kg is administered with a radiation dose of 300 nCi). The radiation dose for subsequent subjects can be adjusted based on the results of the first 2 subjects.

Study groups in NCT03751969
Study group	Role	What they receive
HSK3486	Experimental	0.4 mg/kg of HSK3486 emulsion injection (containing [14C] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg) . Receives: Drug: HSK3486

What is being measured

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

Percentage of cumulative drug excretion of [14C]HSK3486 on biological specimens(urine and faeces) accounting for total radiation drug dose
Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK3486，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces).
Measured: from the start of administration to 96 hours after administration
Maximum Plasma Concentration [Cmax] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: from the start of administration to 96 hours after administration
Time to plasma peak concentration[Tmax] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: from the start of administration to 96 hours after administration
Clearance half-life[t1/2] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: from the start of administration to 96 hours after administration
Area Under the Curve [AUC] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: from the start of administration to 96 hours after administration

Secondary outcomes (13)

Number of patients with adverse events and serious adverse events
Safety Measures
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Blood routine test
Observe the changes of blood routine test during the whole trial
Measured: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Urine routine test
Observe the changes of urine routine test during the whole trial
Measured: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Blood biochemical examination
Observe the changes of Blood biochemical examination during the whole trial
Measured: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Blood pressure
Observe the changes of blood pressure during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Heart rate or pulse
Observe the changes of heart rate or pulse during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Respiratory rate or blood oxygen saturation
Observe the changes of respiratory rate or blood oxygen saturation during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Heart rate of electrocardiogram
Observe the changes of heart rate of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
RR interval of electrocardiogram
Observe the changes of RR interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QT interval of electrocardiogram
Observe the changes of QT interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QTcF interval of electrocardiogram
Observe the changes of QTcF interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
PR interval of electrocardiogram
Observe the changes of PR interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QRS interval of electrocardiogram
Observe the changes of QRS interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)

Timeline

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

30 Mar 20201 Dec 2020

First posted23 Nov 2018
Study start30 Mar 2020
Primary completion1 Nov 2020
Study completion1 Dec 2020

Why it stopped: study canceled

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
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03751969
Sponsor's protocol ID: HSK3486-104-1
Status last verified: May 2022
First submitted: 18 Nov 2018
Last updated: 2 Jun 2022
Results posted: 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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All Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Evaluating the Mass Balance of Micro-dose [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults
ClinicalTrials.gov ID: NCT03751969
Acronym / sponsor ID: HSK3486-104-1
Conditions: Anesthesia, Sedation
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: study canceled
Enrolment: 0 participants (actual)
Lead sponsor: Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
Study start: 30 Mar 2020 (actual)
Primary completion: 1 Nov 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 23 Nov 2018 (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.

Study design

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

Arm	Type	Receives
HSK3486	Experimental	Drug: HSK34860.4 mg/kg of HSK3486 emulsion injection (containing [14C] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg) .

Who may qualify

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

Key inclusion criteria (6 listed)

Subjects enrolled in this study are required to meet all of the following:

Key exclusion criteria (14 listed)

Subjects who meet any of the following will be excluded:
A Subjects with a history of any severe disease, or concomitant diseases or abnormalities that may affect the test results as judged by the investigator, including but not limited to diseases or abnormalities in the circulatory system, endocrine system, neurological system, digestive system, urinary system, hematologic system, immune system, mental and metabolic aspects; B Subjects who have a past or current history of cardiovascular disease, including: heart failure, ischemic heart disease, long QT syndrome, arrhythmia requiring medication; a family history of Adams-Stokes syndrome or long QT syndrome; QTcF interval ≥ 450 ms (corrected by Fridericia's formula); C Subjects who have a past or current history of respiratory disease, including: obstructive pulmonary disease, asthma, or a history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infections within 1 week prior to screening, with significant fever, wheezing, nasal congestion, and coughing.
D Subjects who have a past or current history of gastrointestinal disease, including: gastroesophageal reflux, hemorrhoids or perianal disease with fecal blood, habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, etc.; E Subjects who have major surgery within 6 months before screening, or surgical incision not completely healed. Major surgery includes, but is not limited to any surgery that has a significant risk of bleeding, prolonged general anesthesia, incisional biopsy or significant traumatic injury; F Subjects with hyperactive immune response, including: sensitive to excipients of HSK3486 emulsion injections (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), history of drug allergies (including anesthetics), or other allergic diseases (such as allergic to any food ingredient or have special dietary requirements and cannot follow a uniform diet);

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
HSK3486The first 2 subjects will receive an intravenous injection of 0.4 mg/kg of HSK3486 emulsion injection (containing [14C] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg, i.e. a subject with the body weight of 60 kg is administered with a radiation dose of 300 nCi). The radiation dose for subsequent subjects can be adjusted based on the results of the first 2 subjects.	Drug	HSK3486

Primary outcome

Percentage of cumulative drug excretion of [14C]HSK3486 on biological specimens(urine and faeces) accounting for total radiation drug dose
Time frame: from the start of administration to 96 hours after administration
Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK3486，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces).
Maximum Plasma Concentration [Cmax] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Time frame: from the start of administration to 96 hours after administration
Pharmacokinetic Measures
Time to plasma peak concentration[Tmax] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Time frame: from the start of administration to 96 hours after administration
Pharmacokinetic Measures
Clearance half-life[t1/2] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Time frame: from the start of administration to 96 hours after administration
Pharmacokinetic Measures
Area Under the Curve [AUC] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Time frame: from the start of administration to 96 hours after administration
Pharmacokinetic Measures

13 secondary outcomes

Number of patients with adverse events and serious adverse events
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Blood routine test
Time frame: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Urine routine test
Time frame: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Blood biochemical examination
Time frame: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Blood pressure
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Heart rate or pulse
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Respiratory rate or blood oxygen saturation
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Heart rate of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
RR interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QT interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QTcF interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
PR interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QRS interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.

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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
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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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 2 Jun 2022. 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 was withdrawn before enrolling participants, so there are no results.

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?

Percentage of cumulative drug excretion of [14C]HSK3486 on biological specimens(urine and faeces) accounting for total radiation drug dose (time frame: from the start of administration to 96 hours after administration). The study lists 5 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 NCT03751969.

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 2 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.