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
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug-drug interaction Arm
Drug: HS-10504 · Drug: Itraconazole Capsules
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)。
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
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
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
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
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
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
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
No study locations are listed for this record.
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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Studies of the drug tested here: HS-10504
Jiangsu Hansoh Pharmaceutical Co., Ltd. →