The Phase Ⅰd Clinical Trial of Hydronidone Capsules

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeijing Continent Pharmaceutical Co, Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.;

Disqualifiers

(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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydronidone capsules

    Drug

    SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs

  • Placebo capsules

    Drug

    SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs

Treatment groups

138 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: SAD:180mg drug groupExperimental treatment 1 intervention
Group B: SAD:120mg drug groupExperimental treatment 1 intervention
Group C: SAD:240mg drug groupExperimental treatment 1 intervention
Group D: SAD:300mg drug groupExperimental treatment 1 intervention
Group E: SAD:360mg drug groupExperimental treatment 1 intervention
Group F: SAD:420mg drug groupExperimental treatment 1 intervention
Group G: MAD: drug group1 (dosage to be determined)Experimental treatment 1 intervention
Group H: MAD: drug group 2 (dosage to be determined)Experimental treatment 1 intervention
Group I: MAD: drug group 3 (dosage to be determined)Experimental treatment 1 intervention
Group J: Study on the Interaction between Food and Drugs:drug group1 (dosage to be determined)Experimental treatment 1 intervention
Group K: Study on the Interaction between Food and Drugs:drug group2 (dosage to be determined)Experimental treatment 1 intervention
Group L: SAD:Placebo groupPlacebo comparator 1 intervention
Group M: MAD:Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

SAD :Blood drug PK parameters(Cmax)

Time frame
24 hours after administration
2

SAD:Blood drug PK parameters(Tmax)

Time frame
24 hours after administration
3

SAD:Blood drug PK parameters(AUC0-t)

Time frame
24 hours after administration
4

SAD:Blood drug PK parameters( t1/2)

Time frame
24 hours after administration

Secondary outcomes

1

Hydronidone and its metabolites M3 and M4 blood drug concentrations (SAD)

Time frame
24 hours after administration
2

Hydronidone and its metabolites M3 and M4 blood drug concentrations (MAD)

Time frame
24 hours after administration
3

Safety indicator: Any adverse event

Adverse Event (AE) is defined as any untoward medical occurrence during drug clinical trials, drug therapy, or medical procedures, regardless of its causal relationship to the drug used.

Time frame
48 hours after administration
4

Safety indicators:Chest X-ray examination

Time frame
48 hours after administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Continent Pharmaceutical Co, Ltd.

Lead sponsor

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

Collaborator

This trial is not recruiting at the moment. You can still explore other options: