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GlomerulonephritisPhase 1NCT05505955

Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency

A Phase 1 study testing HRS-5965 in people with Glomerulonephritis, 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 trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts: Part 1: single ascending dose, randomized, double-blind study，with 6 dose groups preset, of which 1 group… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Glomerulonephritis
What is being tested?
HRS-5965
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
1 siteChina
Study dates
8 Oct 2022to 3 Nov 2023
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

  • Healthy subjects study
  • Healthy male or female, age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent);
  • 18.5kg/m2 ≤BMI<30 kg/m2, and the weight of men should be ≥ 50kg, and that of women should be ≥ 45kg.
  • Study on subjects with renal insufficiency
  • Age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent), both men and women can;
  • 18.5kg/m2≤BMI<30 kg/m2；
  • The estimated glomerular filtration rate of subjects with chronic renal insufficiency conforms to 15 ≤ EGFR < 30 ml/min/1.73m2 (calculated according to CKD-EPI formula, see Appendix 2 of the scheme).

Who cannot join

  • Healthy subjects study
  • The researcher has determined that there may be diseases or medical conditions that affect the absorption, distribution, metabolism and excretion of drugs or reduce compliance;
  • The estimated glomerular filtration rate conforms to EGFR < 90 ml/min/1.73m2 (calculated according to CKD-EPI formula, see Appendix 2 of the scheme);
  • According to the judgment of the researcher, any physiological or psychological disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.
  • Study on subjects with renal insufficiency
  • Those who received renal replacement therapy within 12 weeks before screening; Or the two tests in the screening period indicate that the renal function is unstable (the results in the screening period meet the diagnostic criteria of 2012 KDIGO acute renal injury, or the changes that do not meet the above criteria but are judged to be clinically significant by the researcher. If there are reasonable reasons, the third test is allowed, and the interval between two consecutive tests should be more than 3 days but not more than 7 days);
  • According to the judgment of the researcher, the subject has any of the following: in the state of progression or prognosis of disease (including primary renal disease, complications and other complications); The treatment plan needs to be adjusted at any time; Any physical or mental disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated hospital of QingDao University

    Qingdao, Shandong, 266000

Other trials in China

About this study

Official title: A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of Single and Multiple Dose of HRS-5965 Tablets in Healthy Subjects, and the Food Effect on Pharmacokinetics, and Pharmacokinetics in Subjects With Impaired Renal Function

The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts:

Part 1: single ascending dose, randomized, double-blind study，with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; Part 2: Multiple ascending dose, randomized, double-blind study，with 4 dose groups preset; Part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function.

Being tested
HRS-5965, Placebo
Medical subject headings
Glomerulonephritis

What participants receive

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

  • HRS-5965Drug

    Subjects took HRS5965 tablets in Part 1, Part 2 and Part 3.

  • PlaceboDrug

    Subjects took Placebo in Part 1 and Part 2.

Study groups in NCT05505955
Study groupRoleWhat they receive
Part 1Experimentalsingle ascending dose, randomized, double-blind study，with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions. The food impact study consisted of 10 subjects, 8 of whom received HRS-5965 tablets and 2 of whom received placebo. The remaining cohorts required 8 subjects each, with 6 receiving HRS-5965 tablets and 2 receiving placebo.
Receives: Drug: HRS-5965; Drug: Placebo
Part 2ExperimentalMultiple ascending dose, randomized, double-blind study，with 4 dose groups preset; Each dose group consisted of 8 healthy adult subjects randomly assigned 6:2 to HRS-5965 tablets or placebo.
Receives: Drug: HRS-5965; Drug: Placebo
Part 3Experimentalan open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function. Subjects took HRS5965 tablets.
Receives: Drug: HRS-5965

What is being measured

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

  1. The incidence and severity of adverse events to assess safety and tolerability

    Measured: up to 24 days

Secondary outcomes (6)

  1. Area under the plasma concentration versus time curve (AUC) on Day 1 for Part 1 and Part 3

    Measured: Pre-dose to 144 hours post-dose

  2. Peak plasma concentration (Cmax) on Day 1 for Part 1 and Part 3

    Measured: Pre-dose to 144 hours post-dose

  3. Time to maximum plasma concentration (Tmax) on Day 1 for Part 1 and Part 3

    Measured: Pre-dose to 144 hours post-dose

  4. • Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 10 for Part 2

    Measured: Pre-dose to 144 hours post-dose

  5. Peak plasma concentration (Cmax) on Day 1 and Day 10 for Part 2

    Measured: Pre-dose to 144 hours post-dose

  6. Time to maximum plasma concentration (Tmax) on Day 1 and Day 10 for Part 2

    Measured: Pre-dose to 144 hours post-dose

Timeline

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

  1. First posted18 Aug 2022
  2. Study start8 Oct 2022
  3. Primary completion3 Nov 2023
  4. Study completion3 Nov 2023

Resources

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
Randomised
Intervention model
Sequential
Model description
Single-dose and multi-dose, dose escalation, placebo-controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05505955
Sponsor's protocol ID
HRS-5965-101
Status last verified
Oct 2024
First submitted
16 Aug 2022
Last updated
23 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xu Y, Tian F, Ren H, Yu X, Chen X, Ye K, Sun F, Fang L, Li Y, Ban R, Jiang X, Wang C, Ma Y, Kuang F, Li X, Zhang Z, Ye C, Hu M, He F, Shu C, Zou Y, Huang R, Shen K, Xing G, Cao Y. HRS-5965, a small-molecule factor B inhibitor, in healthy participants and participants with renal insufficiency: A first-in-human, phase 1 trial. Med. 2025 Aug 8;6(8):100698. doi: 10.1016/j.medj.2025.100698. Epub 2025 May 15.

    PubMed 40378845

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-5965 in people with Glomerulonephritis, 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 7 inclusion and 7 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 23 Oct 2024. 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?

The incidence and severity of adverse events to assess safety and tolerability (time frame: up to 24 days). 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 NCT05505955, which also lists 1 linked publication.

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 23 Oct 2024.

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