IgA NephropathyPhase 1NCT07035665
A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects
A Phase 1 study testing HRS-5965 Capsules in people with IgA Nephropathy and Paroxysmal Nocturnal Hemoglobinuria, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy, Paroxysmal Nocturnal Hemoglobinuria
- 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
- 16 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 22 Jul 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed the informed consent form pre-trial.
- Aged 18-45 years at signing the informed consent form.
- Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.
Who cannot join
- Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever > 38°C.
- Major trauma/surgery (≤8 weeks) or planned surgery during the study.
- Drug abuse history or positive urine drug screen.
- Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.
Trial locations and contacts
1 site in 1 country.
China1 site
ZhongShan Hospital FuDan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single-Center, Randomized, Open-Label, Crossover Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects
The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.
- Being tested
- HRS-5965 Capsules
- Medical subject headings
- Glomerulonephritis, IGA, Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5965 CapsulesDrug
Oral doses of HRS-5965 capsules at fasted and fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| HRS-5965 Group A | Experimental | Not described Receives: Drug: HRS-5965 Capsules |
| HRS-5965 Group B | Experimental | Not described Receives: Drug: HRS-5965 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax) of HRS-5965
Measured: Day 1 to Day 13.
Area under the plasma concentration - time curve from time 0 to the last quantifiable timepoint (AUC0-t)
Measured: Day 1 to Day 13.
Secondary outcomes (2)
Time to peak concentration (Tmax)
Measured: Day 1 to Day 13.
Adverse events (AEs)
Measured: Day 1 to Day 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start30 Jun 2025
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035665
- Sponsor's protocol ID
- HRS-5965-108
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label, Crossover Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07035665
- Acronym / sponsor ID
- HRS-5965-108
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 25 Jun 2025 (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 evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-5965 Group A | Experimental | Drug: HRS-5965 Capsules |
| HRS-5965 Group B | Experimental | Drug: HRS-5965 Capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed the informed consent form pre-trial.
- Aged 18-45 years at signing the informed consent form.
- Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.
Key exclusion criteria (4 listed)
- Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever > 38°C.
- Major trauma/surgery (≤8 weeks) or planned surgery during the study.
- Drug abuse history or positive urine drug screen.
- Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.
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 doses of HRS-5965 capsules at fasted and fed conditions. | Drug | HRS-5965 Group A, HRS-5965 Group B |
Primary outcome
Peak concentration (Cmax) of HRS-5965
Time frame: Day 1 to Day 13.
Area under the plasma concentration - time curve from time 0 to the last quantifiable timepoint (AUC0-t)
Time frame: Day 1 to Day 13.
2 secondary outcomes
Time to peak concentration (Tmax)
Time frame: Day 1 to Day 13.
Adverse events (AEs)
Time frame: Day 1 to Day 20.
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 20 Aug 2025.
- 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. 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 IgA Nephropathy and Paroxysmal Nocturnal Hemoglobinuria, 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 3 inclusion and 4 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 20 Aug 2025. 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?
Peak concentration (Cmax) of HRS-5965 (time frame: Day 1 to Day 13.). The study lists 2 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 20 Aug 2025.