Peripheral Analgesic and Anti-itchPhase 1NCT05835934

Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK21542 in Healthy Adult Male Volunteers.

A Phase 1 study testing [14C]HSK21542 in people with Peripheral Analgesic and Anti-itch, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK21542 in healthy male subjects. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Peripheral Analgesic and Anti-itch
What is being tested?: [14C]HSK21542
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 15 Jun 2021to 20 Dec 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Chinese males, aged 18-45 years old (inclusive);
Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0-26.0 kg/m2 (inclusive);
Vital signs: blood pressure between 90-139/60-89 mmHg; heart rate or pulse between 60-99 beats/min;
Subjects judged by the investigator based on past medical history, comprehensive physical examination, vital signs examination, and other prescribed tests;
Subjects who voluntarily sign the informed consent form (ICF), able to communicate with the investigator and to complete all trial procedures as per the protocol.

Who cannot join

Clinically significant abnormal results for comprehensive physical examination, vital signs, routine laboratory tests [blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, visual acuity and ophthalmic examination (slit lamp, introcular pressure, and fundoscopy), 12-lead electrocardiogram (ECG), chest X-ray (anteriorposterior), and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
Medication history:
Use of any Western medicine or Chinese patent medicine (including prescription drug, over-the-counter drug, health care product, or live attenuated influenza vaccine) within 14 days prior to screening;
Participation in any clinical trial and interference with other investigational drug or medical device within 3 month prior to screening;
Medical history and surgical history:

Show all 19Show fewer

History of serious clinical diseases or diseases/conditions that the investigator believes may affect the study results, including but not limited to the history of diseases in the motor system, nervous system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, and reproductive system;
Past history of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, long QT syndrome or symptoms and familial history of long QT syndrome (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes);
Have undergone major surgery within 6 months prior to screening or with incomplete healing of the surgical incision; major surgery includes, but is not limited to, any surgery with significant risk of bleeding, prolonged general anesthesia, or incisional biopsy or obvious traumatic injury (excluding cured appendicitis surgery or rectal prolapse surgery);
Severe allergic constitution, including known allergy to any excipient of this investigational product (Glacial acetic acid, sodium acetate, water for injection), two or more drugs and food components, or with special dietary requirements and thus unable to follow a standardized diet;
Living habits:
Long-term excessive consumption (more than 8 cups a day, 1 cup =250mL) of tea, grapefruit, coffee, drinks containing caffeine or grapefruit;
Subjects with a history of alcohol abuse in the three months prior to screening, with an average daily intake of more than 15 g of alcohol (15 g of alcohol is equivalent to 360 mL of beer or 150 mL of wine or 50 mL of liquor containing 40% alcohol), or with a positive alcohol breath test (test value greater than 20 mg/100 mL);
Subjects who smoked more than 5 cigarettes a day or habitually used nicotine-containing products in the 3 months before the screening period and could not quit during the test period;
Drug abuse or dependence, urine screening positive for drug abuse;
Others:
Workers engaged in work requiring prolonged exposure to radioactivity; Or had significant radiation exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-rays) within 1 year or participated in the radiopharma labeling test prior to the test;
Those who had a birth plan during the study period and within 1 year after completion of the study, or who did not agree that the subject and his or her spouse should take strict contraceptive measures (condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) during the study period and within 1 year after completion of the study;
Volunteers judged by the investigator to be unsuitable for participating in this trial for any reason.

Trial locations and contacts

1 site in 1 country.

China1 site

f the First Affiliated Hospital of soochow University
Suzhou, Jiangsu

Other trials in China

About this study

Official title: A Phase I Clinical Study on Absorption, Metabolism, and Excretion of [14C]HSK21542 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK21542 in Human.

This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK21542 in healthy male subjects.

Conditions: Peripheral Analgesic and Anti-itch
Being tested: [14C]HSK21542

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]HSK21542Drug
A single intravenous dose of 2 μg/0.212 μCi/kg [14C]HSK21542 in boluses within 2 minute after fasting for at least 10 hours.

Study groups in NCT05835934
Study group	Role	What they receive
Arms	Experimental	2 μg/0.212 μCi/kg [14C]HSK21542 Receives: Drug: [14C]HSK21542

What is being measured

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

Mass balance
Percentage of cumulative drug excretion of [14C]HSK21542 on biological pecimens(urine and faeces) accounting for total radiation drug dose.
Measured: From the start of administration to 240 h after administration

Secondary outcomes (2)

Area under the concentration-time curve (AUC0-t, AUC0-∞)
Pharmacokinetic Measures
Measured: From the start of administration to 240 h after administration
Peak concentration (Cmax)
Pharmacokinetic Measures
Measured: From the start of administration to 240 h after administration

Timeline

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

15 Jun 202120 Dec 2021

First posted28 Apr 2023
Study start15 Jun 2021
Primary completion10 Sep 2021
Study completion20 Dec 2021

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 Peripheral Analgesic and Anti-itchStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
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
Model description: A single-center, single-dose, non-randomized, open-label design.
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05835934
Sponsor's protocol ID: HSK21542-103
Status last verified: Apr 2023
First submitted: 19 Apr 2023
Last updated: 28 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yuan JJ, Bian YC, Ma S, Chen W, Zhang FY, Zhang H, Miao LY. Pharmacokinetics, Mass Balance and Metabolism of [14C]HSK21542, a Novel Kappa Opioid Receptor Agonist, in Humans. Eur J Drug Metab Pharmacokinet. 2023 Nov;48(6):723-731. doi: 10.1007/s13318-023-00858-0. Epub 2023 Oct 13.
PubMed 37833493

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study on Absorption, Metabolism, and Excretion of [14C]HSK21542 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK21542 in Human.
ClinicalTrials.gov ID: NCT05835934
Acronym / sponsor ID: HSK21542-103
Conditions: Peripheral Analgesic and Anti-itch
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: The First Affiliated Hospital of Soochow University
Study start: 15 Jun 2021 (actual)
Primary completion: 10 Sep 2021 (actual)
Study completion: 20 Dec 2021 (actual)
First posted: 28 Apr 2023 (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, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK21542 in healthy male subjects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A single-center, single-dose, non-randomized, open-label design.

Arm	Type	Receives
Arms	Experimental	Drug: [14C]HSK215422 μg/0.212 μCi/kg [14C]HSK21542

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy Chinese males, aged 18-45 years old (inclusive);
Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0-26.0 kg/m2 (inclusive);
Vital signs: blood pressure between 90-139/60-89 mmHg; heart rate or pulse between 60-99 beats/min;
Subjects judged by the investigator based on past medical history, comprehensive physical examination, vital signs examination, and other prescribed tests;
Subjects who voluntarily sign the informed consent form (ICF), able to communicate with the investigator and to complete all trial procedures as per the protocol.

Key exclusion criteria (19 listed)

Clinically significant abnormal results for comprehensive physical examination, vital signs, routine laboratory tests [blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, visual acuity and ophthalmic examination (slit lamp, introcular pressure, and fundoscopy), 12-lead electrocardiogram (ECG), chest X-ray (anteriorposterior), and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
Use of any Western medicine or Chinese patent medicine (including prescription drug, over-the-counter drug, health care product, or live attenuated influenza vaccine) within 14 days prior to screening;
Participation in any clinical trial and interference with other investigational drug or medical device within 3 month prior to screening;
History of serious clinical diseases or diseases/conditions that the investigator believes may affect the study results, including but not limited to the history of diseases in the motor system, nervous system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, and reproductive system;

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
[14C]HSK21542A single intravenous dose of 2 μg/0.212 μCi/kg [14C]HSK21542 in boluses within 2 minute after fasting for at least 10 hours.	Drug	Arms

Primary outcome

Mass balance
Time frame: From the start of administration to 240 h after administration
Percentage of cumulative drug excretion of [14C]HSK21542 on biological pecimens(urine and faeces) accounting for total radiation drug dose.

2 secondary outcomes

Area under the concentration-time curve (AUC0-t, AUC0-∞)
Time frame: From the start of administration to 240 h after administration
Peak concentration (Cmax)
Time frame: From the start of administration to 240 h 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 28 Apr 2023.
Derived from this study: PubMed 37833493Yuan JJ, Bian YC, Ma S, Chen W, Zhang FY, Zhang H, Miao LY. Pharmacokinetics, Mass Balance and Metabolism of [14C]HSK21542, a Novel Kappa Opioid Receptor Agonist, in Humans. Eur J Drug Metab Pharmacokinet. 2023 Nov;48(6):723-731. doi: 10.1007/s13318-023-00858-0. Epub 2023 Oct 13.
Individual participant dataSharing planned: No

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 principal investigator

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 [14C]HSK21542 in people with Peripheral Analgesic and Anti-itch, run by 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 19 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 28 Apr 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?

Mass balance (time frame: From the start of administration to 240 h after administration). 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 NCT05835934, 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 28 Apr 2023.