Healthy VolunteersPhase 1NCT04213196
Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
A Phase 1 study testing HSK21542 in people with Healthy Volunteers, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HSK21542
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2020to 7 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 18-45 years old (inclusive) at screening;
- Male volunteers no less than 50 kg, or female volunteers no less than 45 kg, with body mass index [BMI] in the range of 18.0-27.0 kg/m2 (inclusive) at screening;
- Healthy volunteers, as assessed by the investigator based on past medical history, comprehensive physical examination, vital signs, and specified tests and examinations.
- Fully understand the nature, purpose, and potential benefits, inconveniences and risks of the trial. Understand the study procedure and voluntarily provide written informed consent.
- Able to communicate with the investigator and to follow all requirements of the study, and willing to be admitted into the phase I clinical facility.
Who cannot join
- Those who have suffered or are currently suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality or any other disease or physiological condition that can interfere with the results;
- Physical examination, vital sign monitoring, ECG examination, chest anteroposterior and lateral radiographs, laboratory examination (including blood routine, urine routine, blood biochemistry, coagulation function, thyroid function, blood pregnancy (only for female subjects) during screening period, and the researcher judged that the abnormality had clinical significance;
- People with positive hepatitis B surface antigen, positive hepatitis C antibody, positive Treponema pallidum antibody, or positive AIDS virus antibody test;
- Patients with QTcF>450 ms in ECG examination during screening;
- Allergic constitution: such as those who are allergic to two or more drugs and foods; Or those who are allergic to any ingredient in this product and auxiliary materials; (Auxiliary materials: glacial acetic acid, sodium acetate, water for injection)
- Those who cannot tolerate venipuncture and/or have a history of blood and needle sickness;
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- Those who have drunk too much tea, grapefruit, coffee, caffeinated or grapefruit drinks for a long time (more than 8 cups a day, 1 cup=250mL);
- Those who have a history of alcohol abuse within 3 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit=12 ounces or 360 mL of beer, 1.5 ounces or 45 mL of spirits with 40% alcohol content, 5 ounces or 150 mL of wine), or those who have positive alcohol breath test;
- Volunteers with a positive urine nicotine test;
- Volunteers with drug abuse or dependence, or with a positive urine drugs of abuse test;
- Those who have used any prescription medicine, over-the-counter medicine, Chinese herbal medicine and health care products within 14 days
- Blood donation or loss of blood > 450 mL within the past 3 months;
- Participation in any clinical trials within the past 3 months;
- Volunteers who plan to become pregnant within the next 6 months;
- Any other factors judged by the investigator to be unsuitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
- Conditions
- Healthy Volunteers
- Being tested
- HSK21542
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK21542Drug
Also called HSK21542 0.2 μg/kg
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
HSK21542Drug
Also called HSK21542 0.5 μg/kg
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
HSK21542Drug
Also called HSK21542 1 μg/kg
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
HSK21542Drug
Also called HSK21542 1 μg/kg
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
HSK21542Drug
Also called HSK21542 0.75 μg/kg
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
HSK21542Drug
Also called HSK21542 1.5 μg/kg
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
HSK21542Drug
Also called HSK21542 2.25 μg/kg
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
HSK21542Drug
Also called HSK21542 3.375 μg/kg
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
HSK21542Drug
Also called HSK21542 0.2 μg/kg
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
| Study group | Role | What they receive |
|---|---|---|
| HSK21542 0.2 μg/kg（15 min) | Experimental | Healthy volunteers 0.2 μg/kg HSK21542 Receives: Drug: HSK21542 |
| HSK21542 0.5 μg/kg | Experimental | Healthy volunteers 0.5 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
| HSK21542 1 μg/kg （15min) | Experimental | Healthy volunteers 1 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
| HSK21542 1 μg/kg （2min) | Experimental | Healthy volunteers 1 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
| HSK21542 0.75 μg/kg | Experimental | Healthy volunteers 0.75 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
| HSK21542 1.5 μg/kg | Experimental | Healthy volunteers 1.5 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
| HSK21542 2.25 μg/kg | Experimental | Healthy volunteers 2.25 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
| HSK21542 3.375 μg/kg | Experimental | Healthy volunteers 3.375 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
| HSK21542 0.2 μg/kg（2min) | Experimental | Healthy volunteers 0.2 μg/kg HSK21542 or Placebo Receives: Drug: HSK21542 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE/serious AE
Adverse event/serious adverse event
Measured: From screening up to 3 weeks
Vital signs: Systolic and Diastolic Blood Pressure
Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers.
Measured: From screening up to 3 weeks
Ramsay sedation score
Ramsay sedation score will be collected
Measured: -60 minutes before administration until 24 hours after administration
Visual analog scale (VAS) addiction score
VAS addiction score will be collected
Measured: from administration to 24 hours after administration
Secondary outcomes (7)
Peak concentration (Cmax)
Cmax（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.
Measured: -30 minutes before administration until 24 hours after administration
Area under the concentration-time curve（AUC）
AUC（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.
Measured: -30 minutes before administration until 24 hours after administration
Tmax
time to peak observed
Measured: -30 minutes before administration until 24 hours after administration
Total clearance
Total clearance
Measured: -30 minutes before administration until 24 hours after administration
Prolactin level
Prolactin level will be collected
Measured: before administration until 24 hours after administration
Antidiuretic hormone level
Antidiuretic hormone level will be collected
Measured: before administration until 24 hours after administration
Urine volume
Urine volume will be collected
Measured: before administration until 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start9 Jan 2020
- Primary completion6 Sep 2020
- Study completion7 Dec 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 Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Yan, PhD, Study director, The Second Affiliated Hospital of Zhejiang University Medical CollegeHong-gang Lou, PhD, Study director, The Second Affiliated Hospital of Zhejiang University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213196
- Sponsor's protocol ID
- HSK21542-102
- Status last verified
- Dec 2019
- First submitted
- 25 Dec 2019
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zollner C, Mousa SA, Fischer O, Rittner HL, Shaqura M, Brack A, Shakibaei M, Binder W, Urban F, Stein C, Schafer M. Chronic morphine use does not induce peripheral tolerance in a rat model of inflammatory pain. J Clin Invest. 2008 Mar;118(3):1065-73. doi: 10.1172/JCI25911.
PubMed 18246198
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04213196
- Acronym / sponsor ID
- HSK21542-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 6 Sep 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 30 Dec 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 first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| HSK21542 0.2 μg/kg（15 min) | Experimental | Drug: HSK21542Healthy volunteers 0.2 μg/kg HSK21542 |
| HSK21542 0.5 μg/kg | Experimental | Drug: HSK21542Healthy volunteers 0.5 μg/kg HSK21542 or Placebo |
| HSK21542 1 μg/kg （15min) | Experimental | Drug: HSK21542Healthy volunteers 1 μg/kg HSK21542 or Placebo |
| HSK21542 1 μg/kg （2min) | Experimental | Drug: HSK21542Healthy volunteers 1 μg/kg HSK21542 or Placebo |
| HSK21542 0.75 μg/kg | Experimental | Drug: HSK21542Healthy volunteers 0.75 μg/kg HSK21542 or Placebo |
| HSK21542 1.5 μg/kg | Experimental | Drug: HSK21542Healthy volunteers 1.5 μg/kg HSK21542 or Placebo |
| HSK21542 2.25 μg/kg | Experimental | Drug: HSK21542Healthy volunteers 2.25 μg/kg HSK21542 or Placebo |
| HSK21542 3.375 μg/kg | Experimental | Drug: HSK21542Healthy volunteers 3.375 μg/kg HSK21542 or Placebo |
| HSK21542 0.2 μg/kg（2min) | Experimental | Drug: HSK21542Healthy volunteers 0.2 μg/kg HSK21542 or Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females aged 18-45 years old (inclusive) at screening;
- Male volunteers no less than 50 kg, or female volunteers no less than 45 kg, with body mass index [BMI] in the range of 18.0-27.0 kg/m2 (inclusive) at screening;
- Healthy volunteers, as assessed by the investigator based on past medical history, comprehensive physical examination, vital signs, and specified tests and examinations.
- Fully understand the nature, purpose, and potential benefits, inconveniences and risks of the trial. Understand the study procedure and voluntarily provide written informed consent.
- Able to communicate with the investigator and to follow all requirements of the study, and willing to be admitted into the phase I clinical facility.
Key exclusion criteria (15 listed)
- Those who have suffered or are currently suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality or any other disease or physiological condition that can interfere with the results;
- Physical examination, vital sign monitoring, ECG examination, chest anteroposterior and lateral radiographs, laboratory examination (including blood routine, urine routine, blood biochemistry, coagulation function, thyroid function, blood pregnancy (only for female subjects) during screening period, and the researcher judged that the abnormality had clinical significance;
- People with positive hepatitis B surface antigen, positive hepatitis C antibody, positive Treponema pallidum antibody, or positive AIDS virus antibody test;
- Patients with QTcF>450 ms in ECG examination during screening;
- Allergic constitution: such as those who are allergic to two or more drugs and foods; Or those who are allergic to any ingredient in this product and auxiliary materials; (Auxiliary materials: glacial acetic acid, sodium acetate, water for injection)
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 |
|---|---|---|
| HSK21542Also: HSK21542 0.2 μg/kgIntravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. | Drug | HSK21542 0.2 μg/kg（15 min) |
| HSK21542Also: HSK21542 0.5 μg/kgIntravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. | Drug | HSK21542 0.5 μg/kg |
| HSK21542Also: HSK21542 1 μg/kgIntravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. | Drug | HSK21542 1 μg/kg （15min) |
| HSK21542Also: HSK21542 1 μg/kgIntravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min. | Drug | HSK21542 1 μg/kg （2min) |
| HSK21542Also: HSK21542 0.75 μg/kgIntravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. | Drug | HSK21542 0.75 μg/kg |
| HSK21542Also: HSK21542 1.5 μg/kgIntravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. | Drug | HSK21542 1.5 μg/kg |
| HSK21542Also: HSK21542 2.25 μg/kgIntravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. | Drug | HSK21542 2.25 μg/kg |
| HSK21542Also: HSK21542 3.375 μg/kgIntravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. | Drug | HSK21542 3.375 μg/kg |
| HSK21542Also: HSK21542 0.2 μg/kgIntravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min. | Drug | HSK21542 0.2 μg/kg（2min) |
Primary outcome
AE/serious AE
Time frame: From screening up to 3 weeks
Adverse event/serious adverse event
Vital signs: Systolic and Diastolic Blood Pressure
Time frame: From screening up to 3 weeks
Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers.
Ramsay sedation score
Time frame: -60 minutes before administration until 24 hours after administration
Ramsay sedation score will be collected
Visual analog scale (VAS) addiction score
Time frame: from administration to 24 hours after administration
VAS addiction score will be collected
7 secondary outcomes
Peak concentration (Cmax)
Time frame: -30 minutes before administration until 24 hours after administration
Area under the concentration-time curve（AUC）
Time frame: -30 minutes before administration until 24 hours after administration
Tmax
Time frame: -30 minutes before administration until 24 hours after administration
Total clearance
Time frame: -30 minutes before administration until 24 hours after administration
Prolactin level
Time frame: before administration until 24 hours after administration
Antidiuretic hormone level
Time frame: before administration until 24 hours after administration
Urine volume
Time frame: before administration until 24 hours after 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 22 Feb 2023.
- Results publication: PubMed 18246198Zollner C, Mousa SA, Fischer O, Rittner HL, Shaqura M, Brack A, Shakibaei M, Binder W, Urban F, Stein C, Schafer M. Chronic morphine use does not induce peripheral tolerance in a rat model of inflammatory pain. J Clin Invest. 2008 Mar;118(3):1065-73. doi: 10.1172/JCI25911.
- Individual participant dataSharing planned: No
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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.
Min Yan, PhD study director
The Second Affiliated Hospital of Zhejiang University Medical College
Hong-gang Lou, PhD study director
The Second Affiliated Hospital of Zhejiang University Medical College
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 HSK21542 in people with Healthy Volunteers, 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 5 inclusion and 15 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 22 Feb 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 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?
AE/serious AE (time frame: From screening up to 3 weeks). The study lists 4 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 NCT04213196, 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 22 Feb 2023.