The Phase Ⅰd Clinical Trial of Hydronidone Capsules

Official title

Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)

Overview

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.

Interventions

• Drug Hydronidone capsules
  SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs
• Drug Placebo capsules
  SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs

Primary outcome measures

• SAD :Blood drug PK parameters(Cmax) [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters（Tmax） [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters（AUC0-t） [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters( t1/2) [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters(AUC0-∞) [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters(λz) [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters(Vd/F) [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters(CL/F) [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters(AUC_%Extrap) [Time frame: 24 hours after administration]
• SAD:Blood drug PK parameters(MRT) [Time frame: 24 hours after administration]

Secondary outcome measures (5)

• Hydronidone and its metabolites M3 and M4 blood drug concentrations (SAD) [Time frame: 24 hours after administration]
• Hydronidone and its metabolites M3 and M4 blood drug concentrations (MAD) [Time frame: 24 hours after administration]
• Safety indicator: Any adverse event [Time frame: 48 hours after administration]
• Safety indicators:Chest X-ray examination [Time frame: 48 hours after administration]
• Safety indicators:12-lead electrocardiogram examination. [Time frame: 48 hours after administration]

Eligibility criteria

Inclusion criteria

• Healthy subjects, both male and female;
• Age: 18-45 years;
• Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)/height² (m²));
• 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.;
• 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

• (Inquiry) Participation in any other clinical trial within three months prior to this study;
• (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 \[particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.\];
• (Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;
• (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);
• Use of any medications (including herbal medicines) or health products within 14 days before the first dose;
• (Inquiry) Individuals with special dietary requirements who cannot adhere to a standardized diet (e.g., intolerance to standard meals) or those with difficulty swallowing;
• (Inquiry) Inability to tolerate venipuncture and/or a history of blood or needle phobia;
• (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;
• (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;
• (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;
• (Inquiry) Occurrence of an acute illness during the pre-study screening phase or before administration of the study drug;
• (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;
• (Inquiry) Surgery within three months before screening or plans to undergo surgery during the study period;
• (Inquiry) History of drug abuse or substance abuse;
• (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;
• (Inquiry) Smoking or use of any tobacco products between screening and hospital admission;
• Positive nicotine test result;
• Alcohol breath test result greater than 0.0 mg/100 mL;
• Positive urine drug screen result;
• Pregnant or breastfeeding women;
• Individuals planning to conceive within 6 months after the trial or unwilling to use non-pharmacological contraceptive measures;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07262346 · KDN-F351-202502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗