[¹⁴C] Hydronidone Mass Balance Study

[¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants

According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a [¹⁴C] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Hepatitis B-related Liver Fibrosis
• Intervention / Treatment: Drug: [¹⁴C]Hydronidone

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhang Ling, Dr; Phone Number: +86-13501209210; Email: zhangling@bjcontinent.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Beijing Gaobo Hospital
      • Contact: Quankun / Xuemei Zhuang/ Liu, Dr; Phone Number: 010-50847588-682; Email: zhuangqk@gobroadhealthcare.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form;
• Chinese adult male participants aged 18 to 50 years (inclusive);
• Participants weighing at least 50 kg at screening, with a body mass index [BMI = weight (kg) / height² (m²)] within the range of 19.0 to 26.0 kg/m² (inclusive);
• Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner.

Exclusion Criteria:

• The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system;
• Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant;
• Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant;
• Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody;
• Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except for appendectomy), or plans to undergo surgery during the trial period;
• A previous diagnosis of Gilbert's syndrome;
• Hemorrhoids with bloody stools or perianal diseases with regular or ongoing bloody stools; severe nausea or vomiting within one week before screening; habitual constipation or diarrhea; or positive fecal occult blood test;
• Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days or 5 half-lives (whichever is longer) prior to dosing; use of strong inhibitors or inducers of UGTs, SULTs, CYP3A4, P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1/3, or any drugs known to prolong the QT/QTc interval or carry a risk of causing torsade de pointes (TdP) within 4 weeks before screening (see Appendix 2 for details); or plans to use any chemical drugs, biologics, traditional Chinese medicines, or natural products during the trial that the researcher deems unsuitable;
• A history of drug allergies or allergic diseases (such as asthma, urticaria, eczematous dermatitis), or a suspected or confirmed allergy to the trial drug (including similar drugs) or any of its excipients as determined by the researcher;
• Participants with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;
• Participation in any other clinical trial drug or interventional clinical study within 3 months before screening;
• Blood donation or blood loss ≥ 400 mL within 3 months before dosing, or blood transfusion or use of blood products within 4 weeks before dosing;
• Difficulty in blood collection or intolerance to venous blood sampling.
• Individuals who work with long-term exposure to radioactive conditions, or those with significant radioactive exposure within 1 year prior to screening (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations), or those who have participated in radiolabeled drug trials within 1 year prior to screening;
• History of drug abuse or substance abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine);
• Average weekly alcohol consumption of ≥14 units within 3 months prior to screening (1 unit ≈ 360 mL beer, or 45 mL liquor, or 150 mL wine), or positive breath alcohol test;
• Average daily smoking of >5 cigarettes (or equivalent nicotine products) within 3 months prior to dosing, or inability to discontinue any tobacco products during the study, or positive cotinine test;
• Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL), and inability to abstain during the study; or consumption of any chocolate, caffeine, or xanthine-rich foods or beverages within 48 hours prior to dosing;
• Vaccination within 4 weeks prior to dosing, or planned vaccination within 1 month after dosing;
• Other reasons deemed by the investigator as making the participant unsuitable for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: [¹⁴C] Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C] Hydronidone); On the morning of Day 1 (D1), a single oral dose was administered under fasting conditions.

Drug: [¹⁴C]Hydronidone; Enrolled participants fasted for at least 10 hours prior to dosing. On the morning of Day 1 (D1), a single oral dose of [¹⁴C]Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C]Hydronidone) was administered under fasting conditions, with approximately 240 mL of water used for preparation and administration. Except for the water used for dosing, no water was permitted within 1 hour before and after administration. Participants remained in the isotope ward of the study center from dosing until Day 9 (D9), which could be shortened or extended depending on whether the sample collection termination criteria were met."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative radioactive recovery in excreta (urine and feces) per collection period	within 9 days after dosing
Cumulative total radioactive recovery in excreta (urine and feces)	within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Cmax	within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : Tmax	within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : t1/2	within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : MRT	within 9 days after dosing
Pharmacokinetic parameters of total radioactivity in plasma : AUC	within 9 days after dosing
Whole blood ratio of total radioactivity concentration	within 9 days after dosing
plasma ratio of total radioactivity concentration	within 9 days after dosing
Percentage of unchanged drug relative to total radioactivity exposure in plasma	within 9 days after dosing
Percentage of unchanged drug in urine relative to the administered dose (%Dose)	within 9 days after dosing
Percentage of unchanged drug in feces relative to the administered dose (%Dose)	within 9 days after dosing
Identification of major metabolites in plasma	within 9 days after dosing
Identification of major metabolites in urine	within 9 days after dosing
Identification of major metabolites in feces	within 9 days after dosing

Collaborators and Investigators

• Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hydronidone; Chronic Hepatitis B-related liver fibrosis
• Other Study ID Numbers: KDN-F351-202506

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No