Postoperative PainPhase 1NCT04110886
Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers
A Phase 1 study testing HSK21542 in people with Postoperative Pain and Chronic Pain, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in Australia.
Trial summary
This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers. The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Chronic Pain
- What is being tested?
- HSK21542
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Jul 2020to 5 Jan 2021
- 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 male and female subjects, age 18-45 years;
- BMI between 18.0-27.0 kg/m2
- Determined by investigator to be in general good health according to medical history, comprehensive physical examination;
- Understanding of the nature, significance, potential benefits and risks of the trial, understanding of the procedures and be able to provide written informed consent voluntarily ;
- Good communication with investigators, compliance with the study requirements and willingness to stay in phase I clinical trial ward as required.
Who cannot join
- Anyone who has suffered or is currently suffering from any serious diseases, that may interfere with the results of the trial;
- Determined by investigator to be abnormal with clinical significance in Physical examination, vital signs monitoring, electrocardiogram, chest radiograph, laboratory examination;
- HBsAg positive, HCV antibody positive, Treponema pallidum antibody positive, or HIV antibody positive;
- QTcF > 450ms;
- Allergic constitution;
- Intolerance of venipuncture and/or history of haemorrhage or needle fainting;
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- Drug or alcohol abuse;
- Have used any prescription, over-the-counter, Chinese herbal medicine or health products within 14 days;
- Blood donation or massive bleeding within 3 months (greater than 450 mL);
- Participants in any drug clinical trial within 3 months.
- Birth planning in the next six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a Kappa Receptor Agonist HSK21542 in Healthy Volunteers
This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers.
The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.
- Conditions
- Postoperative Pain, Chronic Pain
- Being tested
- HSK21542, Placebo
- Keywords
- Pain, Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK21542Drug
Single dose, injection, starting dose of 0.2ug escalating up to 20ug
PlaceboDrug
Single dose, injection matching placebo
| Study group | Role | What they receive |
|---|---|---|
| HSK21542 single ascending doses | Experimental | Not described Receives: Drug: HSK21542 |
| Placebo single dose | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events
Measured: Between screening and 7-9 days after dosing
Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
Measured: Between screening and 7-9 days after dosing
Secondary outcomes (7)
Cmax
Maximum (peak) plasma drug concentration
Measured: From the start of administration to 24 hours after administration
Tmax
Time to reach maximum (peak) plasma concentration following drug administration
Measured: From the start of administration to 24 hours after administration
t1/2
Elimination half-life
Measured: From the start of administration to 24 hours after administration
AUC0-t
Area under the plasma concentration-time curve from time zero to time t.
Measured: From the start of administration to 24 hours after administration
AUC0-inf
Area under the plasma concentration-time curve from time zero to infinity
Measured: From the start of administration to 24 hours after administration
CL
Apparent total body clearance of the drug from plasma
Measured: From the start of administration to 24 hours after administration
Vd
Apparent volume of distribution
Measured: From the start of administration to 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 posted1 Oct 2019
- Study start2 Jul 2020
- Primary completion8 Dec 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Wabnitz, PhD, Principal investigator, CMAX Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110886
- Sponsor's protocol ID
- HSK21542-101
- Status last verified
- Mar 2020
- First submitted
- 27 Aug 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a Kappa Receptor Agonist HSK21542 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04110886
- Acronym / sponsor ID
- HSK21542-101
- Conditions
- Postoperative Pain, Chronic Pain
- Keywords
- Pain, Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 1 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 A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers.
The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK21542 single ascending doses | Experimental | Drug: HSK21542 |
| Placebo single dose | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects, age 18-45 years;
- BMI between 18.0-27.0 kg/m2
- Determined by investigator to be in general good health according to medical history, comprehensive physical examination;
- Understanding of the nature, significance, potential benefits and risks of the trial, understanding of the procedures and be able to provide written informed consent voluntarily ;
- Good communication with investigators, compliance with the study requirements and willingness to stay in phase I clinical trial ward as required.
Key exclusion criteria (11 listed)
- Anyone who has suffered or is currently suffering from any serious diseases, that may interfere with the results of the trial;
- Determined by investigator to be abnormal with clinical significance in Physical examination, vital signs monitoring, electrocardiogram, chest radiograph, laboratory examination;
- HBsAg positive, HCV antibody positive, Treponema pallidum antibody positive, or HIV antibody positive;
- QTcF > 450ms;
- Allergic constitution;
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 |
|---|---|---|
| HSK21542Single dose, injection, starting dose of 0.2ug escalating up to 20ug | Drug | HSK21542 single ascending doses |
| PlaceboSingle dose, injection matching placebo | Drug | Placebo single dose |
Primary outcome
Number of subjects with adverse events
Time frame: Between screening and 7-9 days after dosing
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events
Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
Time frame: Between screening and 7-9 days after dosing
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
7 secondary outcomes
Cmax
Time frame: From the start of administration to 24 hours after administration
Tmax
Time frame: From the start of administration to 24 hours after administration
t1/2
Time frame: From the start of administration to 24 hours after administration
AUC0-t
Time frame: From the start of administration to 24 hours after administration
AUC0-inf
Time frame: From the start of administration to 24 hours after administration
CL
Time frame: From the start of administration to 24 hours after administration
Vd
Time frame: From the start of administration to 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 9 Feb 2021.
- 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.
Paul Wabnitz, PhD principal investigator
CMAX Clinical Research Pty Ltd
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 Postoperative Pain and Chronic Pain, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in Australia.
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 11 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 9 Feb 2021. 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 Australia. 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?
Number of subjects with adverse events (time frame: Between screening and 7-9 days after dosing). 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 9 Feb 2021.