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Not yet recruitingNCT07764692Updated Aug 14, 2026

A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504

A Phase 1 interventional study of HS-10504 and Itraconazole Capsules in Healthy Participants, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. (part of Hansoh Pharmaceutical Group Company Limited) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 137 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily sign the form prior to the study, fully understand the study content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the protocol;
  2. Adult male and female participants (aged ≥18 years, calculated on the day of signing the informed consent form);
  3. Agree to practice highly effective from the signing of the informed consent form until 6 months after the last dose of HS-10504 and have no plans for reproduction or sperm/egg donation during this period.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with abnormalities in physical examination, vital signs, 12-lead , chest X-ray (posteroanterior and lateral views), clinical laboratory tests, abdominal and renal ultrasound, etc., during the screening period, which are deemed unsuitable for enrollment by the investigator.
  2. Subjects with a history of severe diseases of the nervous, psychiatric, digestive, circulatory, respiratory, or urinary systems, or currently having such diseases, or newly diagnosed diseases before administration of the product, which are assessed by the investigator as unsuitable for participation in this trial.
  3. Subjects who have had surgery within 3 months prior to screening, or have planned surgery during the trial, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion, and are deemed unsuitable for enrollment by the investigator.
  4. Subjects who have participated in any other clinical trial and received any investigational drug/device within 3 months prior to screening.
  5. Subjects with a history of severe allergies, or allergic constitution, or known allergy to any component of the investigational product, or a history of to drugs with chemical structures similar to HS-10504 or belonging to the same class as HS-10504.
  6. Subjects with a history of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or those with a positive result in drug abuse screening.
  7. Subjects who are habitual drinkers within 3 months prior to screening, or those who cannot abstain from alcohol during the trial, or those with a positive breath alcohol test during screening.
  8. Subjects who have smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or those who cannot refrain from using any tobacco products during the trial.
  9. Subjects who have consumed excessive amounts of tea, coffee, or caffeinated beverages within 3 months prior to screening.
  10. Subjects who have had significant blood loss (≥400 mL) or donated blood within 3 months prior to screening, or donated blood or lost blood ≥200 mL within 1 month, or those who plan to donate blood during the trial.
  11. Subjects who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (excluding topical agents with local effects) within 30 days prior to the first dose of the investigational product, or who have used any drug within a period less than 7 half-lives (whichever is longer) before dosing.
  12. Subjects who are lactating within 1 month prior to screening or during the trial, or female participants with a positive pregnancy test, or those who have had unprotected sexual intercourse within 14 days prior to screening.
  13. Subjects with special dietary requirements, unable to comply with the unified diet, or with dysphagia.
  14. Subjects who cannot tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia.
  15. Subjects who may be unable to complete the trial for other reasons or are deemed unsuitable for participation by the investigator.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Drug-drug interaction Arm

    Drug: HS-10504 · Drug: Itraconazole Capsules

Interventions

  • Participants will receive a single oral dose of 400 mg HS-10504 tablets on study days D1 and D15, respectively。

  • Participants will receive itraconazole capsules 0.2 g orally once daily from Day 11 to Day 23 for 13 consecutive days (with co-administration of itraconazole and HS-10504 on an empty stomach on Day 15)。

06

What researchers measure

Primary outcomes

  1. Evaluation of PK parameters of HS-10504 and M6-2: Cmax

    To evaluate the Cmax of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole

    Time frame: 216 hours after administration of HS-10504

  2. Evaluation of PK parameters of HS-10504 and M6-2: AUC0-t

    To evaluate the AUC0-t of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole

    Time frame: 216 hours after administration of HS-10504

  3. Evaluation of PK parameters of HS-10504 and M6-2:AUC0-∞

    To evaluate the AUC0-∞ of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole

    Time frame: 216 hours after administration of HS-10504

Secondary outcomes

  1. Evaluation of PK parameters of HS-10504 and M6-2: Tmax

    To evaluate the Tmax of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole

    Time frame: 216 hours after administration of HS-10504

  2. Evaluation of PK parameters of HS-10504 and M6-2: t1/2z

    To evaluate the t1/2z of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole

    Time frame: 216 hours after administration of HS-10504

  3. Evaluation of PK parameters of HS-10504 and M6-2: λz

    To evaluate the λz of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole

    Time frame: 216 hours after administration of HS-10504

  4. Adverse events

    To evaluate the vital signs of HS-10504 administered alone and in combination with itraconazole

    Time frame: Up to end of the study, approximately 8 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07764692
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Aug 14, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: HS-10504

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