Paroxysmal Nocturnal Hemoglobinuria (PNH)Phase 1NCT07152288
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
A Phase 1 study testing HSK39297 tablets in people with Paroxysmal Nocturnal Hemoglobinuria (PNH), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- What is being tested?
- HSK39297 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2025to Nov 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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 18-70 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): 18~32 kg/m2 (including the threshold);
- Normal or abnormal physical examination, 12-ECG, vital signs, chest frontal and lateral radiographs/CT, abdominal ultrasound, and laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.) in the screening and baseline periods were not clinically significant.
- The demographic means of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
- BMI matched to the hepatic impairment group (Group A + Group B) with a mean value ± 15%;
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- Age-matched to the hepatic impairment group (Group A + Group B), mean ± 10 years;
- Sex-matched to liver impairment group (Group A + Group B), mean value ± 1 case;
- Glomerular filtration rate (eGFR) ≥75 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaborative Study Group (CKD-EPI) formula;
- Subjects with childbearing potential must agree to have no plans for childbearing and voluntarily use highly effective contraception with their partner from the time of signing the ICF until 1 month after administration of the test drug, and to avoid sperm/egg donation. Female subjects of childbearing potential must have a negative serum pregnancy test at both screening and baseline and not be breastfeeding.
- For subjects with hepatic impairment, the following inclusion criteria must also be met:
- Not on medication within 4 weeks prior to screening, or have at least 4 weeks of stable medication for hepatic impairment and/or other co-morbidities requiring long-term treatment;
- Child-Pugh classification of Class A or B (without the use of albumin within 14 days), which is chronic liver injury caused by previous primary liver diseases, including but not limited to non-alcoholic steatohepatitis, viral hepatitis (hepatitis B, hepatitis C), etc.
Who cannot join
- Smoked an average of more than 5 cigarettes per day in the past 3 months or those who cannot comply with the prohibition of smoking during the trial;
- Known or suspected (as judged by the researcher) immunodeficiency diseases or hereditary complement deficiencies;
- Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
- Screen those who have a history of heavy drinking in the past 3 months (with an average daily alcohol consumption of > 2 units of alcohol (1 unit = 285 mL of beer, or 30 mL of spirits, or 100 mL of wine)) or those with a positive breath alcohol test;
- 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;
- History of capsular bacterial infection in the past; including but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae type b, etc;
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- Severe trauma or undergone surgery within 2 weeks prior to screening, or plan to undergo surgery during the trial period;
- Participated in a clinical trial of any other drug or medical device within 3 months prior to screening or plan to do so during the study period, or still within 5 half-lives of the drug prior to screening (whichever is longer);
- A previous diagnosis of malignant tumors (excluding radically resected basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix);
- History of drug or substance abuse; or a positive urine drug test at screening;
- Donated or lost ≥ 400 mL of blood within 30 days, or received a blood transfusion prior to screening;
- QTcF (males) > 480 ms at screening, or other 12-ECG abnormalities judged by the investigator to be clinically significant or unsuitable for participation;
- Difficulty in swallowing, collecting blood intravenously, or physically unable to tolerate blood collection, or not expected to complete the entire trial follow-up;
- Vaccined within 2 weeks prior to dosing or plan to receive the vaccine during the study;
- Positive result in the screening of any of the following indicators: hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody (hepatitis B surface antigen and hepatitis C antibody can be positive in subjects in the liver insufficiency group).
- Any physical or psychological disease or condition that, in the judgment of the investigator, is likely to increase the risk of the trial, interfere with compliance with the protocol and ability to complete the trial.
- Additional exclusion criteria for subjects with hepatic impairment:
- History of any serious disease other than the primary disease of the liver itself, or a history of and/or abnormal clinically significant clinical laboratory tests that, in the opinion of the investigator, may affect the results of the test, including, but not limited to, a history of circulatory, endocrine, neurological, gastrointestinal, urologic, or hematologic, immunologic, psychiatric, and metabolic disorders;
- Liver failure, or cirrhosis with combination of hepatic encephalopathy (West-Haven Level 2 and above), hepatocellular carcinoma (except for those with Barcelona Clinic Liver Cancer (BCLC) stage 0 or those who have achieved radical treatment results), ruptured variceal hemorrhage of the esophagogastric fundus vein, and other complications that, in the judgment of the investigator, make the subject unsuitable for participation in the study;
- On systemic hormones (except subjects on stable use of ≤ 5 mg/day of prednisone or equivalent doses of glucocorticoids) or other immunosuppressive agents within 4 weeks prior to screening, or more than 4 weeks from their last immunosuppressive therapy at screening but are still within the drug's efficacy period (as assessed by the investigator);
- Alpha-fetoprotein > 20 ng/mL; hemoglobin (Hb) ≤ 70 g/L; alanine aminotransferase (ALT) or mentholatum aminotransferase (AST) ≥ 5 times the upper limit of normal (ULN); severe active bleeding or a platelet level ≤30×10⁹/L (except for those judged by the investigator to be in a stable state);
- History of liver transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Ying Zhou, 010-64009673, zhouying0321@126.com
About this study
Official title: A Single-dose, Open-label, Phase I Study Comparing the Pharmacokinetics, Safety, and Pharmacodynamics of HSK39297 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function
- Being tested
- HSK39297 tablets
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK39297 tabletsDrug
oral
HSK39297 tabletsDrug
oral
HSK39297 tabletsDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Subjects with mild hepatic impairment. Receives: Drug: HSK39297 tablets |
| Treatment group B | Experimental | Subjects with moderate hepatic impairment. Receives: Drug: HSK39297 tablets |
| Treatment group C | Experimental | Subjects with normal hepatic function Receives: Drug: HSK39297 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum plasma concentration.
Measured: Post-dose at day 1 to day 10.
AUC0-t
Area under the concentration curve from time 0 to the last quantifiable concentration
Measured: Post-dose at day 1 to day 10
AUC0-inf
Area under the concentration curve from time 0 to extrapolated infinite time
Measured: Post-dose at day 1 to day 10
Secondary outcomes (5)
Tmax
Time to maximum plasma concentration
Measured: Post-dose at day 1 to day 10
t1/2
Terminal half-life
Measured: Post-dose at day 1 to day 10
CL/F
Apparent clearance
Measured: Post-dose at day 1 to day 10
Vz/F
Apparent volume of distribution
Measured: Post-dose at day 1 to day 10
Incidence and severity of adverse events
Measured: Screening period up to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start29 May 2025
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152288
- Sponsor's protocol ID
- HSK39297-103
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label, Phase I Study Comparing the Pharmacokinetics, Safety, and Pharmacodynamics of HSK39297 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07152288
- Acronym / sponsor ID
- HSK39297-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Sep 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 pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HSK39297 tabletsSubjects with mild hepatic impairment. |
| Treatment group B | Experimental | Drug: HSK39297 tabletsSubjects with moderate hepatic impairment. |
| Treatment group C | Experimental | Drug: HSK39297 tabletsSubjects with normal hepatic function |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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 18-70 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): 18~32 kg/m2 (including the threshold);
- Normal or abnormal physical examination, 12-ECG, vital signs, chest frontal and lateral radiographs/CT, abdominal ultrasound, and laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.) in the screening and baseline periods were not clinically significant.
- The demographic means of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
Key exclusion criteria (22 listed)
- Smoked an average of more than 5 cigarettes per day in the past 3 months or those who cannot comply with the prohibition of smoking during the trial;
- Known or suspected (as judged by the researcher) immunodeficiency diseases or hereditary complement deficiencies;
- Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components;
- Screen those who have a history of heavy drinking in the past 3 months (with an average daily alcohol consumption of > 2 units of alcohol (1 unit = 285 mL of beer, or 30 mL of spirits, or 100 mL of wine)) or those with a positive breath alcohol test;
- 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;
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 |
|---|---|---|
| HSK39297 tabletsoral | Drug | Treatment group A |
| HSK39297 tabletsoral | Drug | Treatment group B |
| HSK39297 tabletsoral | Drug | Treatment group C |
Primary outcome
Cmax
Time frame: Post-dose at day 1 to day 10.
The maximum plasma concentration.
AUC0-t
Time frame: Post-dose at day 1 to day 10
Area under the concentration curve from time 0 to the last quantifiable concentration
AUC0-inf
Time frame: Post-dose at day 1 to day 10
Area under the concentration curve from time 0 to extrapolated infinite time
5 secondary outcomes
Tmax
Time frame: Post-dose at day 1 to day 10
t1/2
Time frame: Post-dose at day 1 to day 10
CL/F
Time frame: Post-dose at day 1 to day 10
Vz/F
Time frame: Post-dose at day 1 to day 10
Incidence and severity of adverse events
Time frame: Screening period up to day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 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.
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 HSK39297 tablets in people with Paroxysmal Nocturnal Hemoglobinuria (PNH), run by Haisco Pharmaceutical Group 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 13 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 3 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Meixia (028-67258779, chenmeixia@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Post-dose at day 1 to day 10.). The study lists 3 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 3 Sep 2025.