Healthy Participants
Conditions
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.
Interventions
DRUGHS-10504
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)。
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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; 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 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.
Exclusion criteria
1. 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. 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 investigational 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 hypersensitivity 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of PK parameters of HS-10504 and M6-2: Cmax | 216 hours after administration of HS-10504 | 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 | 216 hours after administration of HS-10504 | 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-∞ | 216 hours after administration of HS-10504 | To evaluate the AUC0-∞ of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of PK parameters of HS-10504 and M6-2: Tmax | 216 hours after administration of HS-10504 | 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 | 216 hours after administration of HS-10504 | 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 | 216 hours after administration of HS-10504 | To evaluate the λz of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole |
| Adverse events | Up to end of the study, approximately 8 months | To evaluate the vital signs of HS-10504 administered alone and in combination with itraconazole |
Outcome results
None listed