Chronic Kidney DiseasesPhase 1NCT07557407
A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects
A Phase 1 study testing [14C]HRS-1780 in people with Chronic Kidney Diseases, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- [14C]HRS-1780
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Aged 18 to 45 years old (inclusive) who are in good health and have signed the informed consent form on that day.
- 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).
- 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.
Who cannot join
- 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.
- Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV Ab), human immunodeficiency virus (HIV), or syphilis at screening.
- 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.
- 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.
- 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).
- 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.
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- 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.
- Whole blood/plasma donation or loss ≥ 200 mL of blood within 3 months prior to dosing; received a blood/plasma transfusion.
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jinan Central Hospital, Affiliated to Shandong First Medical University
Jinan, Shandong, 250013
Qing Wen, +86-0531-55865012, wenq0619@126.com
Qing Wen
About this study
Official title: 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- [14C]HRS-1780
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]HRS-1780Drug
[14C]HRS-1780, oral.
| Study group | Role | What they receive |
|---|---|---|
| [14C]HRS-1780 Group | Experimental | Oral, single dose. Receives: Drug: [14C]HRS-1780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity ratio of whole blood/plasma.
Measured: 0 to anticipated 11 days.
Tmax
Time to reach maximum concentration (Tmax).
Measured: 0 to anticipated 11 days.
Cmax
Maximum concentration (Cmax).
Measured: 0 to anticipated 11 days.
AUClast
Area under the concentration time curve from time point 0 to the last quantifiable time point (AUClast).
Measured: 0 to anticipated 11 days.
AUC0-inf
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf).
Measured: 0 to anticipated 11 days.
t1/2
Half-life (t1/2).
Measured: 0 to anticipated 11 days.
CL/F
Apparent clearance (CL/F).
Measured: 0 to anticipated 11 days.
Vz/F
Apparent volume of distribution (Vz/F).
Measured: 0 to anticipated 11 days.
%AUC
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC).
Measured: 0 to anticipated 11 days.
%Dose
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose).
Measured: 0 to anticipated 11 days.
Total radioactivity ratio for blood/plasma.
Measured: 0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces.
Measured: 0 to anticipated 11 days.
Secondary outcomes (1)
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs.
Measured: 0 to anticipated 11 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-dose, non-randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557407
- Sponsor's protocol ID
- HRS-1780-105
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07557407
- Acronym / sponsor ID
- HRS-1780-105
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-dose, non-randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| [14C]HRS-1780 Group | Experimental | Drug: [14C]HRS-1780Oral, single dose. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- Aged 18 to 45 years old (inclusive) who are in good health and have signed the informed consent form on that day.
- 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).
- 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.
Key exclusion criteria (12 listed)
- 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.
- Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV Ab), human immunodeficiency virus (HIV), or syphilis at screening.
- 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.
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]HRS-1780[14C]HRS-1780, oral. | Drug | [14C]HRS-1780 Group |
Primary outcome
Total radioactivity ratio of whole blood/plasma.
Time frame: 0 to anticipated 11 days.
Tmax
Time frame: 0 to anticipated 11 days.
Time to reach maximum concentration (Tmax).
Cmax
Time frame: 0 to anticipated 11 days.
Maximum concentration (Cmax).
AUClast
Time frame: 0 to anticipated 11 days.
Area under the concentration time curve from time point 0 to the last quantifiable time point (AUClast).
AUC0-inf
Time frame: 0 to anticipated 11 days.
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf).
t1/2
Time frame: 0 to anticipated 11 days.
Half-life (t1/2).
CL/F
Time frame: 0 to anticipated 11 days.
Apparent clearance (CL/F).
Vz/F
Time frame: 0 to anticipated 11 days.
Apparent volume of distribution (Vz/F).
%AUC
Time frame: 0 to anticipated 11 days.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC).
%Dose
Time frame: 0 to anticipated 11 days.
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose).
Total radioactivity ratio for blood/plasma.
Time frame: 0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces.
Time frame: 0 to anticipated 11 days.
1 secondary outcome
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs.
Time frame: 0 to anticipated 11 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]HRS-1780 in people with Chronic Kidney Diseases, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing He (+86-0518-82342973, jing.he@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactivity ratio of whole blood/plasma. (time frame: 0 to anticipated 11 days.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.