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

NCT07764692 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-10504-112
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  216 hours after administration of HS-10504

Secondary Outcomes (4)

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

  216 hours after administration of HS-10504

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

  216 hours after administration of HS-10504

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

  216 hours after administration of HS-10504

• Adverse events

  Up to end of the study, approximately 8 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug-drug interaction Arm

Drug: HS-10504; Drug: Itraconazole Capsules

Interventions

HS-10504 DRUG

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

Experimental group

Itraconazole Capsules DRUG

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)。

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent 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;
• Adult male and female participants (aged ≥18 years, calculated on the day of signing the informed consent form);
• Agree to practice highly effective contraception 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.

You may not qualify if:

• Subjects with clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, 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.
• 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 investigational product, which are assessed by the investigator as unsuitable for participation in this trial.
• 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.
• Subjects who have participated in any other clinical trial and received any investigational drug/device within 3 months prior to screening.
• Subjects with a history of severe allergies, or allergic constitution, or known allergy to any component of the investigational product, or a history of hypersensitivity to drugs with chemical structures similar to HS-10504 or belonging to the same class as HS-10504.
• 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.
• 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.
• 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.
• Subjects who have consumed excessive amounts of tea, coffee, or caffeinated beverages within 3 months prior to screening.
• 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.
• 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.
• 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.
• Subjects with special dietary requirements, unable to comply with the unified diet, or with dysphagia.
• Subjects who cannot tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia.
• Subjects who may be unable to complete the trial for other reasons or are deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08