Hemolytic AnemiaPhase 1NCT06684041
A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects
A Phase 1 study testing HRS-5965 capsule in people with Hemolytic Anemia, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemolytic Anemia
- What is being tested?
- HRS-5965 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2024to 7 Apr 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
- Voluntarily sign the informed consent form before any activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict accordance with the clinical trial protocol.
- Aged between 18 and 45 years old (based on the time of signing the informed consent form), both males and females are eligible.
- The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 26 kg/m².
- During the screening period, there are no abnormalities in physical examination, vital signs, twelve - lead electrocardiogram, frontal and lateral chest radiographs, abdominal ultrasound, and laboratory tests, or those with minor abnormalities but judged by the investigator to be of no clinical significance.
- 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) are all negative.
- Complete the vaccination of Neisseria meningitidis and Streptococcus pneumoniae vaccines 2 weeks before the first administration of HRS - 5965.
Who cannot join
- 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.
- 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.
- Those with a previous history of Neisseria meningitidis infection, or those whose first - degree relatives have a history of Neisseria meningitidis infection.
- Those with definite evidence of infection within 2 weeks before screening (positive etiological examination, or having received systemic antibiotic treatment), or those who have had a body temperature exceeding 38 °C.
- Subjects with abnormal serum electrolytes (hypokalemia, hypomagnesemia, hypocalcemia).
- Subjects with a history of convulsive disorders, long QT syndrome (including family history), syncope while swimming or any other type of syncope or history of loss of consciousness.
Show all 9Show fewer
- Subjects with a previous history of heart disease, such as hypertension, atherosclerosis, heart failure, bradycardia or stroke, or those using a pacemaker.
- Those with a serum creatinine level exceeding the upper limit of the normal value, or those whose level does not exceed the upper limit but are judged by the investigator to be at risk of renal function impairment.
- Those with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal value (ULN), or with total bilirubin exceeding 1.5 times the ULN.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study of Multiple Doses of HRS-5965 Capsules in Healthy Subjects and a Phase I Clinical Trial of the Effect of HRS-5965 on QT Interval in Healthy Subjects
This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.
- Conditions
- Hemolytic Anemia
- Being tested
- HRS-5965 capsule, HRS-5965 capsule placebo
- 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 capsuleDrug
HRS-5965 capsule
HRS-5965 capsule placeboDrug
HRS-5965 capsule placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Not described Receives: Drug: HRS-5965 capsule; Drug: HRS-5965 capsule placebo |
| Dose 2 | Experimental | Not described Receives: Drug: HRS-5965 capsule; Drug: HRS-5965 capsule placebo |
| Dose 3 | Experimental | Not described Receives: Drug: HRS-5965 capsule; Drug: HRS-5965 capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects with adverse events (AEs)
Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation.
Measured: Baseline up to seven days after the last dosing.
QTcF: Baseline and placebo-adjusted QTcF after oral HRS-5965 capsules
Measured: Baseline up to 24 hours after dosing.
Secondary outcomes (8)
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for HRS-5965
Measured: Baseline up to seven days after the last dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for HRS-5965
Measured: Baseline up to seven days after the last dosing.
Maximum plasma concentration (Cmax) for HRS-5965
Measured: Baseline up to seven days after the last dosing.
Time to reach maximum plasma concentration (Tmax) for HRS-5965
Measured: Baseline up to seven days after the last dosing.
Terminal half-life (t1/2) for HRS-5965
Measured: Baseline up to seven days after the last dosing.
Apparent clearance (CL/F) of HRS-5965 for administration subcutaneously
Measured: Baseline up to seven days after the last dosing.
Apparent volume of distribution (V/F) of HRS-5965 for administration subcutaneously
Measured: Baseline up to seven days after the last dosing.
Complement system alternative pathway (AP) inhibition efficiency
Measured: Baseline up to seven days after the last dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start9 Nov 2024
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic AnemiaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT06684041
- Sponsor's protocol ID
- HRS-5965-106
- Status last verified
- Jul 2025
- First submitted
- 1 Nov 2024
- Last updated
- 4 Jul 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 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study of Multiple Doses of HRS-5965 Capsules in Healthy Subjects and a Phase I Clinical Trial of the Effect of HRS-5965 on QT Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06684041
- Acronym / sponsor ID
- HRS-5965-106
- Conditions
- Hemolytic Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 12 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.
This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: HRS-5965 capsule, Drug: HRS-5965 capsule placebo |
| Dose 2 | Experimental | Drug: HRS-5965 capsule, Drug: HRS-5965 capsule placebo |
| Dose 3 | Experimental | Drug: HRS-5965 capsule, Drug: HRS-5965 capsule placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily sign the informed consent form before any activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict accordance with the clinical trial protocol.
- Aged between 18 and 45 years old (based on the time of signing the informed consent form), both males and females are eligible.
- The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 26 kg/m².
- During the screening period, there are no abnormalities in physical examination, vital signs, twelve - lead electrocardiogram, frontal and lateral chest radiographs, abdominal ultrasound, and laboratory tests, or those with minor abnormalities but judged by the investigator to be of no clinical significance.
- 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) are all negative.
Key exclusion criteria (9 listed)
- 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.
- 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.
- Those with a previous history of Neisseria meningitidis infection, or those whose first - degree relatives have a history of Neisseria meningitidis infection.
- Those with definite evidence of infection within 2 weeks before screening (positive etiological examination, or having received systemic antibiotic treatment), or those who have had a body temperature exceeding 38 °C.
- Subjects with abnormal serum electrolytes (hypokalemia, hypomagnesemia, hypocalcemia).
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 capsuleHRS-5965 capsule | Drug | Dose 1, Dose 2, Dose 3 |
| HRS-5965 capsule placeboHRS-5965 capsule placebo | Drug | Dose 1, Dose 2, Dose 3 |
Primary outcome
Incidence of subjects with adverse events (AEs)
Time frame: Baseline up to seven days after the last dosing.
Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation.
QTcF: Baseline and placebo-adjusted QTcF after oral HRS-5965 capsules
Time frame: Baseline up to 24 hours after dosing.
8 secondary outcomes
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Maximum plasma concentration (Cmax) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Time to reach maximum plasma concentration (Tmax) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Terminal half-life (t1/2) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Apparent clearance (CL/F) of HRS-5965 for administration subcutaneously
Time frame: Baseline up to seven days after the last dosing.
Apparent volume of distribution (V/F) of HRS-5965 for administration subcutaneously
Time frame: Baseline up to seven days after the last dosing.
Complement system alternative pathway (AP) inhibition efficiency
Time frame: Baseline up to seven days after the last dosing.
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 4 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
Sickle Cell Disease, Sickle Cell Anaemia
RecruitingPhase 2
Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis
Severe Aplastic Anemia (SAA), Hypo-Plastic Myelodysplastic Syndrome (MDS)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
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 capsule in people with 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 6 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 4 Jul 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?
Incidence of subjects with adverse events (AEs) (time frame: Baseline up to seven days after the last dosing.). 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 4 Jul 2025.