Complement Mediated Primary or Secondary Glomerular DiseasesPhase 1NCT06674915

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment

A Phase 1 study testing HRS-5965 capsules in people with Complement Mediated Primary or Secondary Glomerular Diseases, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Complement Mediated Primary or Secondary Glomerular Diseases
What is being tested?: HRS-5965 capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 26 Nov 2024to 16 Jan 2026
Phase: Phase 1
Are there results?: None posted in the registry

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing;
Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female;
At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold);
Subjects with childbearing potential must agree to have no plans for childbearing and voluntarily use highly effective contraception with their partner from the time of signing the ICF until 1 month after administration of the test drug, and to avoid sperm/egg donation. Female subjects of childbearing potential must have a negative serum pregnancy test at both screening and baseline and not be breastfeeding.
For subjects with hepatic impairment, the following inclusion criteria must also be met:
Not on medication within 4 weeks prior to screening, or have at least 4 weeks of stable medication for hepatic impairment and/or other co-morbidities requiring long-term treatment;

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Child-Pugh classification of Class A or B.
For subjects with normal hepatic function, the following inclusion criteria must also be met:
The demographic means of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
Weight matched to the hepatic impairment group (Group A + Group B) with a mean value ± 10 kg;
Age-matched to the hepatic impairment group (Group A + Group B), mean ± 10 years;
Sex-matched to liver impairment group (Group A + Group B), mean value ± 1 case;
Normal or abnormal physical examination, 12-ECG, vital signs, chest frontal and lateral radiographs/CT, abdominal ultrasound, and laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.) in the screening and baseline periods were not clinically significant.

Who cannot join

Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
Disease or medical condition that, in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, and excretion of the drug or that may reduce compliance;
Prior history of meningococcal infection or a first-degree relative with a history of meningococcal infection;
Existing or suspected infection (at the investigator's discretion) within 2 weeks prior to screening, or fever;
Severe trauma or undergone surgery within 8 weeks prior to screening, or plan to undergo surgery during the trial period;
Participated in a clinical trial of any other drug or medical device within 3 months prior to screening or plan to do so during the study period, or still within 5 half-lives of the drug prior to screening (whichever is longer);

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Smoked an average of more than 5 cigarettes per day in the 4 weeks, or consumed an average of more than 15 g of alcohol in a day in the 4 weeks prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-potency liquor), or a positive breath alcohol test at baseline;
History of drug or substance abuse; or a positive urine drug test at screening;
Donated or lost ≥ 400 mL of blood within 8 weeks, or received a blood transfusion within 12 weeks prior to screening;
Malignant tumor, or history of a malignant tumor within 5 years prior to screening (except for primary hepatocellular carcinoma treated with radical surgery without recurrence within 2 years, non-melanoma of the skin for which treatment has been administered without signs of recurrence, and resected cervical intraepithelial neoplasia);
Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening;
QTcF (males) > 450 ms and a QTcF (females) > 470 ms at screening, or other 12-ECG abnormalities judged by the investigator to be clinically significant or unsuitable for participation;
Glomerular filtration rate (eGFR) < 75 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaborative Study Group (CKD-EPI) formula;
Difficulty in swallowing, collecting blood intravenously, or physically unable to tolerate blood collection, or not expected to complete the entire trial follow-up;
Vaccinated within 2 weeks prior to dosing or plan to receive the vaccine during the study and within 1 month after dosing;
Pre-existing recurrent oral ulcers;
Any physical or psychological disease or condition that, in the judgment of the investigator, is likely to increase the risk of the trial, interfere with compliance with the protocol and ability to complete the trial.
Additional exclusion criteria for subjects with hepatic impairment (excluded if 1 of these criteria is met):
History of liver transplantation;
Liver failure, or cirrhosis with combination of hepatic encephalopathy, hepatocellular carcinoma, ruptured variceal hemorrhage of the esophagogastric fundus vein, and other complications that, in the judgment of the investigator, make the subject unsuitable for participation in the study;
History of any serious disease other than the primary disease of the liver itself, or a history of and/or abnormal clinically significant clinical laboratory tests that, in the opinion of the investigator, may affect the results of the test, including, but not limited to, a history of circulatory, endocrine, neurological, gastrointestinal, urologic, or hematologic, immunologic, psychiatric, and metabolic disorders;
Positive Human Immunodeficiency Virus (HIV) antigen/antibody screen; if syphilis spirochete antibody is positive, additional tolulized red unheated serum test (TRUST) is required, and exclusion is required if TRUST is positive at the same time; if Hepatitis B Surface Antigen (HBsAg) is positive, additional Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Quantitative Test is required, and if Hepatitis C Virus If hepatitis C virus (HCV) antibody (Anti-HCV) is positive, additional quantitative hepatitis C virus (HCV) ribonucleic acid (RNA) testing is required, and exclusion will be determined by the investigator based on the quantitative results;
Alpha-fetoprotein > 20 ng/mL; hemoglobin (Hb) ≤ 70 g/L; alanine aminotransferase (ALT) or mentholatum aminotransferase (AST) ≥ 5 times the upper limit of normal (ULN);
On systemic hormones (except subjects on stable use of ≤ 5 mg/day of prednisone or equivalent doses of glucocorticoids) or other immunosuppressive agents within 4 weeks prior to screening, or more than 4 weeks from their last immunosuppressive therapy at screening but are still within the drug's efficacy period (as assessed by the investigator);
On herbal medications within 4 weeks prior to screening;
On albumin within 14 days prior to screening.
Additional exclusion criteria for subjects with normal hepatic function (excluded if 1 of these criteria is met):
Pre-existing serious primary diseases of vital organs, including but not limited to gastrointestinal, respiratory, renal, hepatic, neurological, hematological, endocrine, oncological, immunological, psychiatric, or cardiovascular diseases;
Positive for any of the HBsAg, Anti-HCV, HIV antigen/antibody, or syphilis spirochete antibody tests;
On any medication (including prescription drugs, over-the-counter medications, herbal medicines, proprietary Chinese medicines and dietary supplements, etc.) within 4 weeks prior to screening; or within 5 half-lives of the medication at the time of screening (whichever is longer).

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215008

Other trials in China

About this study

Official title: A Single-dose, Open-label, Phase I Study Comparing the Pharmacokinetics, Safety, and Pharmacodynamics of HRS-5965 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function

The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.

Conditions: Complement Mediated Primary or Secondary Glomerular Diseases
Being tested: HRS-5965 capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-5965 capsulesDrug
Oral 50 mg.

Study groups in NCT06674915
Study group	Role	What they receive
Treatment group A	Experimental	Subjects with mild hepatic impairment. Receives: Drug: HRS-5965 capsules
Treatment group B	Experimental	Subjects with moderate hepatic impairment. Receives: Drug: HRS-5965 capsules
Treatment group C	Experimental	Subjects with normal hepatic function. Receives: Drug: HRS-5965 capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
The maximum plasma concentration.
Measured: Post-dose at day 1 to day 9.
AUClast
Area under the concentration curve from time 0 to the last quantifiable concentration.
Measured: Post-dose at day 1 to day 9.
AUCinf
Area under the concentration curve from time 0 to extrapolated infinite time.
Measured: Post-dose at day 1 to day 9.

Secondary outcomes (6)

Tmax
Time to maximum plasma concentration.
Measured: Post-dose at day 1 to day 9.
t1/2
Terminal half-life.
Measured: Post-dose at day 1 to day 9.
CL/F
Apparent clearance.
Measured: Post-dose at day 1 to day 9.
Vz/F
Apparent volume of distribution.
Measured: Post-dose at day 1 to day 9.
Incidence and severity of adverse events
Measured: Screening period up to day 9.
Change from baseline of alternative pathway activity
Measured: Post-dose at day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 202416 Jan 2026

First posted5 Nov 2024
Study start26 Nov 2024
Primary completion16 Jan 2026
Study completion16 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Complement Mediated Primary or Secondary Glomerular DiseasesStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06674915
Sponsor's protocol ID: HRS-5965-103
Status last verified: Jan 2026
First submitted: 4 Nov 2024
Last updated: 30 Jan 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Open-label, Phase I Study Comparing the Pharmacokinetics, Safety, and Pharmacodynamics of HRS-5965 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
ClinicalTrials.gov ID: NCT06674915
Acronym / sponsor ID: HRS-5965-103
Conditions: Complement Mediated Primary or Secondary Glomerular Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 26 Nov 2024 (actual)
Primary completion: 16 Jan 2026 (actual)
Study completion: 16 Jan 2026 (actual)
First posted: 5 Nov 2024 (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 is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment group A	Experimental	Drug: HRS-5965 capsulesSubjects with mild hepatic impairment.
Treatment group B	Experimental	Drug: HRS-5965 capsulesSubjects with moderate hepatic impairment.
Treatment group C	Experimental	Drug: HRS-5965 capsulesSubjects with normal hepatic function.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing;
Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female;
At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold);
Subjects with childbearing potential must agree to have no plans for childbearing and voluntarily use highly effective contraception with their partner from the time of signing the ICF until 1 month after administration of the test drug, and to avoid sperm/egg donation. Female subjects of childbearing potential must have a negative serum pregnancy test at both screening and baseline and not be breastfeeding.
Not on medication within 4 weeks prior to screening, or have at least 4 weeks of stable medication for hepatic impairment and/or other co-morbidities requiring long-term treatment;

Key exclusion criteria (30 listed)

Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
Disease or medical condition that, in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, and excretion of the drug or that may reduce compliance;
Prior history of meningococcal infection or a first-degree relative with a history of meningococcal infection;
Existing or suspected infection (at the investigator's discretion) within 2 weeks prior to screening, or fever;
Severe trauma or undergone surgery within 8 weeks prior to screening, or plan to undergo surgery during the trial period;

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
HRS-5965 capsulesOral 50 mg.	Drug	Treatment group A, Treatment group B, Treatment group C

Primary outcome

Cmax
Time frame: Post-dose at day 1 to day 9.
The maximum plasma concentration.
AUClast
Time frame: Post-dose at day 1 to day 9.
Area under the concentration curve from time 0 to the last quantifiable concentration.
AUCinf
Time frame: Post-dose at day 1 to day 9.
Area under the concentration curve from time 0 to extrapolated infinite time.

6 secondary outcomes

Tmax
Time frame: Post-dose at day 1 to day 9.
t1/2
Time frame: Post-dose at day 1 to day 9.
CL/F
Time frame: Post-dose at day 1 to day 9.
Vz/F
Time frame: Post-dose at day 1 to day 9.
Incidence and severity of adverse events
Time frame: Screening period up to day 9.
Change from baseline of alternative pathway activity
Time frame: Post-dose at day 1.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
Individual participant dataSharing planned: Undecided

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 HRS-5965 capsules in people with Complement Mediated Primary or Secondary Glomerular Diseases, run by Chengdu 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 13 inclusion and 30 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: finished, as of the sponsor's last update on 30 Jan 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Post-dose at day 1 to day 9.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06674915.

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 30 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.