Paroxysmal Nocturnal Hemoglobinuria，IgA NephropathyPhase 1NCT06490991
Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects
A Phase 1 study testing HRS-5965 tablets；HRS-5965 capsules in people with Paroxysmal Nocturnal Hemoglobinuria，IgA Nephropathy, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is designed as a single-center, randomized, open-label, cross-over phase I clinical trial with the intention of recruiting 16 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
- Paroxysmal Nocturnal Hemoglobinuria，IgA Nephropathy
- What is being tested?
- HRS-5965 tablets；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
- 17 Jul 2024to 10 Sep 2024
- 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
- Voluntarily sign an informed consent form before the start of this trial, and be able to understand the procedures and methods of this trial. Willing to strictly follow the clinical trial protocol to complete this trial.
- Healthy subject is male aged between 18 and 45 years (including both ends, subject to signing of informed consent form);
- Body weight ≥ 50 kg, and body mass index (BMI): 19-26 kg/m2 (including both ends);
- Physical examination, vital signs, 12 lead electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests during the screening period show no abnormalities, or there are slight abnormalities that have been determined by the researcher to have no clinical significance;
- Human immunodeficiency virus antibody (HIV Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) were all negative during the screening period;
- Male subjects with partners who are fertile women, who have no plans to conceive or donate sperm within 3 months after signing the informed consent form and voluntarily adopt efficient contraceptive measures (including partners);
Who cannot join
- Individuals who are allergic to two or more allergens, or who have been determined by the researcher to be potentially allergic to the investigational drug or its components;
- According to the judgment of researchers, there may be diseases or medical conditions that may affect drug absorption, distribution, metabolism, and excretion, or may reduce compliance;
- Patients with comorbidities such as cardiovascular, liver, kidney, digestive tract, psychiatric, hematological, metabolic abnormalities, and immunodeficiency;
- Individuals with a history of meningococcal infection or first-degree relatives with a history of meningococcal infection;
- Screening for individuals with clear evidence of infection (positive pathogen test or previous systemic antibiotic treatment) or those with a body temperature exceeding 38 ℃ within the first two weeks;
- Screening for individuals who have experienced severe trauma or surgery within the first 8 weeks, or plan to undergo surgery during the trial period;
Show all 19Show fewer
- Screening for clinical trials involving any other drugs or medical devices within the first 4 weeks or planned during the study period, or those who are still within 5 half-lives of the drugs before screening (whichever is longer);
- Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, traditional Chinese patent medicines and simple preparations and dietary supplements) within 4 weeks before screening; Or select those who are within 5 half-lives of the drug at the time of screening (whichever is longer);
- Those whose blood creatinine levels exceed the upper limit of normal values, or those who have not exceeded the upper limit but have been determined by the researcher to have a possibility of renal function damage;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal values (ULN), or total bilirubin exceeding 1.5 times ULN;
- When screening, individuals with QTcF>450 msec (male) , or other clinically significant abnormalities determined by the researcher;
- Individuals with a history of blood donation or severe blood loss (blood loss ≥ 400 mL) within the 8 weeks prior to screening, or those who have received blood transfusions within the 12 weeks prior to screening;
- Those who have used drugs or drugs in the past; Or those who tested positive for urine medication during screening;
- Screening for individuals who smoke an average of 5 or more cigarettes per day within the first 4 weeks;
- The average daily alcohol intake in the four weeks before screening exceeds 15 g (15 g alcohol is equivalent to 450 mL beer, 150 mL wine or 50 mL low alcohol Baijiu), or the alcohol breath test is positive during screening;
- Difficulty swallowing, difficulty in venous blood collection, or physical condition unable to withstand blood collection; Or subjects who are expected to be unable to complete the entire trial follow-up;
- Those who receive the vaccine within 2 weeks before the first administration or within 1 month after the last administration during the study period;
- Subjects with a history of recurrent oral ulcers;
- According to the judgment of the researcher, any physiological or psychological illness or condition that may increase the trial risk, affect the participant's compliance with the protocol, or affect the participant's completion of the trial, as well as any other situation determined by the researcher that the participant is not suitable to participate in the clinical study.
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 Clinical Study Evaluating the Relative Bioavailability of HRS-5965 Capsules and Tablets in Healthy Subjects .
The study is designed as a single-center, randomized, open-label, cross-over phase I clinical trial with the intention of recruiting 16 healthy subjects.
- Being tested
- HRS-5965 tablets；HRS-5965 capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5965 tablets；HRS-5965 capsulesDrug
Medication regimen: 1 Drug: HRS-5965 tablets Medication regimen: 2 Drug: HRS-5965 capsules
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Medication regimen 1-2 | Experimental | Not described Receives: Drug: HRS-5965 tablets；HRS-5965 capsules |
| Arm B: Medication regimen 2-1 | Experimental | Not described Receives: Drug: HRS-5965 tablets；HRS-5965 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative bioavailability (Fr) values between HRS-5965 capsules and HRS-5965 tablets taken on an empty stomach
Measured: 0-144hours
Relative bioavailability (Fr) values of HRS-5965 capsules taken on an empty stomach
Measured: 0-144hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start17 Jul 2024
- Primary completion6 Aug 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Nocturnal Hemoglobinuria，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
- NCT06490991
- Sponsor's protocol ID
- HRS-5965-102
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2024
- Last updated
- 24 Dec 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Relative Bioavailability of HRS-5965 Capsules and Tablets in Healthy Subjects .
- ClinicalTrials.gov ID
- NCT06490991
- Acronym / sponsor ID
- HRS-5965-102
- 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
- 17 Jul 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 8 Jul 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 designed as a single-center, randomized, open-label, cross-over phase I clinical trial with the intention of recruiting 16 healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Medication regimen 1-2 | Experimental | Drug: HRS-5965 tablets；HRS-5965 capsules |
| Arm B: Medication regimen 2-1 | Experimental | Drug: HRS-5965 tablets；HRS-5965 capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily sign an informed consent form before the start of this trial, and be able to understand the procedures and methods of this trial. Willing to strictly follow the clinical trial protocol to complete this trial.
- Healthy subject is male aged between 18 and 45 years (including both ends, subject to signing of informed consent form);
- Body weight ≥ 50 kg, and body mass index (BMI): 19-26 kg/m2 (including both ends);
- Physical examination, vital signs, 12 lead electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests during the screening period show no abnormalities, or there are slight abnormalities that have been determined by the researcher to have no clinical significance;
- Human immunodeficiency virus antibody (HIV Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) were all negative during the screening period;
Key exclusion criteria (19 listed)
- Individuals who are allergic to two or more allergens, or who have been determined by the researcher to be potentially allergic to the investigational drug or its components;
- According to the judgment of researchers, there may be diseases or medical conditions that may affect drug absorption, distribution, metabolism, and excretion, or may reduce compliance;
- Patients with comorbidities such as cardiovascular, liver, kidney, digestive tract, psychiatric, hematological, metabolic abnormalities, and immunodeficiency;
- Individuals with a history of meningococcal infection or first-degree relatives with a history of meningococcal infection;
- Screening for individuals with clear evidence of infection (positive pathogen test or previous systemic antibiotic treatment) or those with a body temperature exceeding 38 ℃ within the first two weeks;
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 tablets；HRS-5965 capsulesMedication regimen: 1 Drug: HRS-5965 tablets Medication regimen: 2 Drug: HRS-5965 capsules | Drug | Arm A: Medication regimen 1-2, Arm B: Medication regimen 2-1 |
Primary outcome
The relative bioavailability (Fr) values between HRS-5965 capsules and HRS-5965 tablets taken on an empty stomach
Time frame: 0-144hours
Relative bioavailability (Fr) values of HRS-5965 capsules taken on an empty stomach
Time frame: 0-144hours
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 24 Dec 2025.
- 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 tablets；HRS-5965 capsules in people with Paroxysmal Nocturnal Hemoglobinuria，IgA Nephropathy, 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 6 inclusion and 19 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 24 Dec 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 relative bioavailability (Fr) values between HRS-5965 capsules and HRS-5965 tablets taken on an empty stomach (time frame: 0-144hours). 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 24 Dec 2025.