The Phase Ⅰd Clinical Trial of Hydronidone Capsules

Beijing Continent Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Liver Fibrosis

Treatments: Drug: Placebo capsules; Drug: Hydronidone capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07262346

KDN-F351-202502

Details and patient eligibility

About

Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects, both male and female;
2. Age: 18-45 years;
3. Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)/height² (m²));
4. Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;
5. Have been fully informed about the nature, significance, potential benefits, possible inconveniences, and risks of the study prior to participation, and voluntarily agree to take part in this clinical trial. Subjects must be able to communicate well with the researchers, comply with all study requirements, and have the capacity to understand and sign the written informed consent form.

Exclusion criteria

1. (Inquiry) Participation in any other clinical trial within three months prior to this study;
2. (Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders [particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.];
3. (Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;
4. (Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);
5. Use of any medications (including herbal medicines) or health products within 14 days before the first dose;
6. (Inquiry) Individuals with special dietary requirements who cannot adhere to a standardized diet (e.g., intolerance to standard meals) or those with difficulty swallowing;
7. (Inquiry) Inability to tolerate venipuncture and/or a history of blood or needle phobia;
8. (Inquiry) Habitual excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL); or consumption of any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) within 48 hours before the first dose, or adherence to any special diet that may affect drug absorption, distribution, metabolism, or excretion;
9. (Inquiry) History of excessive alcohol consumption (defined as more than 28 standard units per week for men and more than 21 standard units per week for women (1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine)); or regular alcohol consumption (more than 14 standard units per week) within 6 months prior to the trial; or consumption of any alcohol-containing products within 24 hours before the first dose;
10. (Inquiry) Blood donation or significant blood loss (exceeding 450 mL) within 3 months before the first dose, or plans to donate blood or blood components during the study or within 3 months after its completion;
11. (Inquiry) Occurrence of an acute illness during the pre-study screening phase or before administration of the study drug;
12. (Inquiry) Consumption of any foods or beverages known to induce or inhibit hepatic metabolic enzymes (e.g., grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which are rich in flavonoids or citrus glycosides) within 24 hours before the first dose;
13. (Inquiry) Surgery within three months before screening or plans to undergo surgery during the study period;
14. (Inquiry) History of drug abuse or substance abuse;
15. (Inquiry) Smoking more than 5 cigarettes per day within 14 days before screening, or inability to discontinue the use of any tobacco products during the trial period;
16. (Inquiry) Smoking or use of any tobacco products between screening and hospital admission;
17. Positive nicotine test result;
18. Alcohol breath test result greater than 0.0 mg/100 mL;
19. Positive urine drug screen result;
20. Pregnant or breastfeeding women;
21. Individuals planning to conceive within 6 months after the trial or unwilling to use non-pharmacological contraceptive measures;
22. Any condition deemed by the investigator as potentially affecting the subject's ability to provide informed consent, comply with the trial protocol, or participate in the trial in a way that could impact the results or subject safety.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 13 patient groups, including a placebo group

SAD:180mg drug group

Experimental group

Description:

On the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once.

Treatment:

Drug: Hydronidone capsules

SAD:120mg drug group

Experimental group

Description:

On the morning of D1, the patients took 120mg of hydronidone capsules orally on an empty stomach once.

Treatment:

Drug: Hydronidone capsules

SAD:240mg drug group

Experimental group

Description:

On the morning of D1, the patients took 240mg of hydronidone capsules orally on an empty stomach once.

Treatment:

Drug: Hydronidone capsules

SAD:300mg drug group

Experimental group

Description:

On the morning of D1, the patients took 300mg of hydronidone capsules orally on an empty stomach once.

Treatment:

Drug: Hydronidone capsules

SAD:360mg drug group

Experimental group

Description:

On the morning of D1, the patients took 360mg of hydronidone capsules orally on an empty stomach once.

Treatment:

Drug: Hydronidone capsules

SAD:420mg drug group

Experimental group

Description:

On the morning of D1, the patients took 420mg of hydronidone capsules orally on an empty stomach once.

Treatment:

Drug: Hydronidone capsules

MAD: drug group1 (dosage to be determined)

Experimental group

Description:

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

Treatment:

Drug: Hydronidone capsules

MAD: drug group 2 (dosage to be determined)

Experimental group

Description:

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

Treatment:

Drug: Hydronidone capsules

MAD: drug group 3 (dosage to be determined)

Experimental group

Description:

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

Treatment:

Drug: Hydronidone capsules

Study on the Interaction between Food and Drugs:drug group1 (dosage to be determined)

Experimental group

Description:

Period 1 involved administration under fasting conditions, with a 7-day washout period starting on Day 2. Administration for Period 2 was conducted on Day 8.

Treatment:

Drug: Hydronidone capsules

Study on the Interaction between Food and Drugs:drug group2 (dosage to be determined)

Experimental group

Description:

In Period 1, a high-fat meal was consumed first, followed by drug administration within 30 minutes, with washout commencing on Day 2. After a total 7-day washout period, the second period of dosing was administered on Day 8.

Treatment:

Drug: Hydronidone capsules

SAD:Placebo group

Placebo Comparator group

Description:

On the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once.

Treatment:

Drug: Placebo capsules

MAD:Placebo group

Placebo Comparator group

Description:

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

Treatment:

Drug: Placebo capsules