A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects

An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]HRS-1780 After a Single Oral Dose to Healthy Male Subjects

The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]HRS-1780 following an oral single dose in healthy adult male participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: [14C]HRS-1780

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jing He; Phone Number: +86-0518-82342973; Email: jing.he@hengrui.com
• Study Contact Backup: Name: Yue Fei; Phone Number: +86-0518-82342973; Email: yue.fei@hengrui.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital, Affiliated to Shandong First Medical University
      • Principal Investigator: Qing Wen
      • Contact: Qing Wen; Phone Number: +86-0531-55865012; Email: wenq0619@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be willing to complete the research as required by the trial protocol.
2. Aged 18 to 45 years old (inclusive) who are in good health and have signed the informed consent form on that day.
3. Body weight of no less than 50 kg and a body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (inclusive).
4. Participants (including their partners) shall have no intention to have children or donate sperm within three months after signing the informed consent form and shall voluntarily adopt the contraceptive measures stipulated in the protocol.

Exclusion Criteria:

1. Clinically significant abnormalities in vital signs (complete physical examination, laboratory tests, biochemistry, urinalysis, coagulation function, stool routine and occult blood, thyroid function), 12-lead electrocardiogram, digital rectal examination, chest X-rays, abdominal ultrasound.
2. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV Ab), human immunodeficiency virus (HIV), or syphilis at screening.
3. Receipt of medical devices or another investigational drug (including placebo) within the previous 3 months or within the 5 half-lives (whichever is longer), and plan to participate in other clinical trials of drugs or medical devices during the trial period.
4. History of illicit or prescription drug abuse in the past five years or drug addiction within 3 months of screening, or positive urine drug screen at screening/baseline.
5. Use of any prescription medicine within 2 weeks, or over-the-counter (OTC) medicine, herbal remedy, or nutritional supplement, or within 5 half-lives of any drugs, whichever is longer prior to dosing, except for vitamins and occasional use of paracetamol (≤ 2 g/day; no more than 3 consecutive days).
6. History or evidence of clinically significant disorders (including but not limited to immunologic, hepatic, renal, digestive, urinary, psychiatric, respiratory, hematologic, endocrine, or metabolic disorders) and deemed not suitable to participate in the study by the investigator.
7. Severe systemic infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plan to do surgeries during the study.
8. Whole blood/plasma donation or loss ≥ 200 mL of blood within 3 months prior to dosing; received a blood/plasma transfusion.
9. Alcohol abuse or consumption of more than 14 units of alcohol per week within the previous 6 months (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); or those who have taken alcohol-containing products within 48 hours before administration; or those with a positive alcohol breath test at baseline; or those who were unable to abstain from alcohol during the trial.
10. History of excessive smoking in the past 1 month prior to screening which is defined as more than 5 cigarettes daily (or products with an equivalent amount of nicotine); or positive cotinine test at baseline, or unable to abstain from smoking within 48 h prior to D-1/check-in and during the trial.
11. Receipt of a vaccine within 2 weeks prior to administration or are scheduled to receive a vaccine during the study period and within 1 month after administration.
12. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.

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]HRS-1780 Group; Oral, single dose.	Drug: [14C]HRS-1780; [14C]HRS-1780, oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total radioactivity ratio of whole blood/plasma.		0 to anticipated 11 days.
Tmax	Time to reach maximum concentration (Tmax).	0 to anticipated 11 days.
Cmax	Maximum concentration (Cmax).	0 to anticipated 11 days.
AUClast	Area under the concentration time curve from time point 0 to the last quantifiable time point (AUClast).	0 to anticipated 11 days.
AUC0-inf	Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf).	0 to anticipated 11 days.
t1/2	Half-life (t1/2).	0 to anticipated 11 days.
CL/F	Apparent clearance (CL/F).	0 to anticipated 11 days.
Vz/F	Apparent volume of distribution (Vz/F).	0 to anticipated 11 days.
%AUC	Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC).	0 to anticipated 11 days.
%Dose	Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose).	0 to anticipated 11 days.
Total radioactivity ratio for blood/plasma.		0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces.		0 to anticipated 11 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs.	0 to anticipated 11 days.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: HRS-1780-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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