Complement Mediated Glomerular DiseasesPhase 1NCT07040787
Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects
A Phase 1 study testing HRS-5965 Capsules, Clopidogrel and Clarithromycin in people with Complement Mediated Glomerular Diseases and Hemolytic Anemia, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to compare the drug-drug interaction of HRS-5965 with clopidogrel and clarithromycin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Complement Mediated Glomerular Diseases, Hemolytic Anemia
- What is being tested?
- HRS-5965 Capsules, Clopidogrel and Clarithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2025to 17 Aug 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
- 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 18-45 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): 19~26 kg/m2 (including the threshold).
- During the screening period, human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV-Ab) were all negative.
- Female subjects with reproductive capacity or male subjects whose partners are female subjects with reproductive capacity need to have no plans for fertility or sperm/egg donation within 3 months +1 week for male subjects and 6 months +1 week for female subjects from the date of signing the informed consent form until the last medication use, and voluntarily take efficient contraceptive measures (including partners).
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.
- Patients with a previous history of coronary artery disease, severe cardiac insufficiency, conduction disorders or clinically significant bradycardia.
- Patients with a history of electrolyte disorders (such as hypomagnesemia).
- Patients with a history of congenital or acquired QT interval prolongation or ventricular arrhythmia.
- Those with a history of meningococcal infection and streptococcus pneumoniae infection.
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- Those with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism poisoning) and poliomyelitis.
- Subjects who have had or are currently suffering from active pathological bleeding.
- Subjects with a previous history of recurrent oral ulcers.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330019
About this study
Official title: A Single-center, Single-arm, Fixed-sequence Drug-drug Interaction Study of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects
The study is being conducted to compare the drug-drug interaction of HRS-5965 with clopidogrel and clarithromycin in healthy subjects.
- Being tested
- HRS-5965 Capsules, Clopidogrel, Clarithromycin
- Medical subject headings
- Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5965 CapsulesDrug
Oral HRS-5965 capsules.
ClopidogrelDrug
Oral clopidogrel.
ClarithromycinDrug
Oral clarithromycin.
| Study group | Role | What they receive |
|---|---|---|
| Drug-drug interaction between HRS-5965 and clopidogrel | Experimental | Not described Receives: Drug: HRS-5965 Capsules; Drug: Clopidogrel |
| Drug-drug interaction between HRS-5965 and clarithromycin | Experimental | Not described Receives: Drug: HRS-5965 Capsules; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
Measured: Day 1 to day 12.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)
Measured: Day 1 to day 12.
Secondary outcomes (3)
Time to maximum plasma concentration
Measured: Day 1 to day 12.
Terminal half-life (t1/2)
Measured: Day 1 to day 12.
Incidence and severity of adverse events (AEs)
Measured: Day 1 up to day 19.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start8 Jul 2025
- Primary completion17 Aug 2025
- Study completion17 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complement Mediated 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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT07040787
- Sponsor's protocol ID
- HRS-5965-107
- Status last verified
- Aug 2025
- First submitted
- 18 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, Single-arm, Fixed-sequence Drug-drug Interaction Study of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07040787
- Acronym / sponsor ID
- HRS-5965-107
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 17 Aug 2025 (actual)
- Study completion
- 17 Aug 2025 (actual)
- First posted
- 27 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 compare the drug-drug interaction of HRS-5965 with clopidogrel and clarithromycin in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-drug interaction between HRS-5965 and clopidogrel | Experimental | Drug: HRS-5965 Capsules, Drug: Clopidogrel |
| Drug-drug interaction between HRS-5965 and clarithromycin | Experimental | Drug: HRS-5965 Capsules, Drug: Clarithromycin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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 18-45 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): 19~26 kg/m2 (including the threshold).
- During the screening period, human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV-Ab) were all negative.
- Female subjects with reproductive capacity or male subjects whose partners are female subjects with reproductive capacity need to have no plans for fertility or sperm/egg donation within 3 months +1 week for male subjects and 6 months +1 week for female subjects from the date of signing the informed consent form until the last medication use, and voluntarily take efficient contraceptive measures (including partners).
Key exclusion criteria (9 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.
- Patients with a previous history of coronary artery disease, severe cardiac insufficiency, conduction disorders or clinically significant bradycardia.
- Patients with a history of electrolyte disorders (such as hypomagnesemia).
- Patients with a history of congenital or acquired QT interval prolongation or ventricular arrhythmia.
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 HRS-5965 capsules. | Drug | Drug-drug interaction between HRS-5965 and clarithromycin, Drug-drug interaction between HRS-5965 and clopidogrel |
| ClopidogrelOral clopidogrel. | Drug | Drug-drug interaction between HRS-5965 and clopidogrel |
| ClarithromycinOral clarithromycin. | Drug | Drug-drug interaction between HRS-5965 and clarithromycin |
Primary outcome
The maximum plasma concentration (Cmax)
Time frame: Day 1 to day 12.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 to day 12.
3 secondary outcomes
Time to maximum plasma concentration
Time frame: Day 1 to day 12.
Terminal half-life (t1/2)
Time frame: Day 1 to day 12.
Incidence and severity of adverse events (AEs)
Time frame: Day 1 up to day 19.
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, Clopidogrel and Clarithromycin in people with Complement Mediated Glomerular Diseases and Hemolytic Anemia, 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 5 inclusion and 9 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?
The maximum plasma concentration (Cmax) (time frame: Day 1 to day 12.). 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.