This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
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.
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.
Single group
HS-10504
DrugParticipants will receive a single oral dose of 400 mg HS-10504 tablets on study days D1 and D15, respectively。
Itraconazole Capsules
DrugParticipants 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
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
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
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
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
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
Adverse events
To evaluate the vital signs of HS-10504 administered alone and in combination with itraconazole
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