Paroxysmal Nocturnal Hemoglobinuria (PNH)Phase 1NCT06852092
Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects
A Phase 1 study testing Carbon-14 labeled HSK39297 in people with Paroxysmal Nocturnal Hemoglobinuria (PNH), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HSK39297 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- What is being tested?
- Carbon-14 labeled HSK39297
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2024to 10 Dec 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy male subjects aged between 18 and 45 years old (inclusive, at the time of signing the informed consent form);
- Body weight ≥ 50 kg and body mass index (BMI) within the range of 19 - 26 kg/m² (inclusive);
- Capable of comprehending the procedures and methodologies of this study, disposed to strictly adhere to the related requirements of the protocol, and capable of signing the informed consent form.
Who cannot join
- Abnormal and clinically significant findings in physical examination, vital signs, laboratory tests (blood routine, biochemistry, coagulation function, urine routine, stool routine + fecal occult blood, thyroid function), ophthalmic examination (slit lamp, intraocular pressure, fundus photography), 12 - lead electrocardiogram [QT interval corrected by Fridericia method (QTcF), 350 - 450 ms (inclusive) for men], X - ray chest film (anterior - posterior and lateral views), abdominal B - ultrasound (liver, gallbladder, pancreas, spleen), urinary system B - ultrasound (kidneys, ureters, bladder, prostate), etc.
- Positive for hepatitis B surface antigen, hepatitis C virus IgG antibody, human immunodeficiency virus antibody and antigen p24, and Treponema pallidum antibody.
- Use of prescription drugs, over - the - counter drugs, or health care products, including Chinese patent medicine, within 14 days before the screening period or within 5 half - lives of the drug (whichever is longer).
- Participated in a clinical trial and received investigational drugs or devices within 3 months before screening.
- Use of any drugs that inhibit or induce the activity of liver drug - metabolizing enzymes or P - gp inhibitors within 30 days before screening.
- Dysphagia or any conditions that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy).
Show all 24Show fewer
- Habitual constipation/diarrhea (feces collection required), history of malabsorption syndrome, or severe GI symptoms within 1 week before screening.
- History of serious diseases in cardiovascular, digestive, etc. systems or other diseases/physiological conditions interfering with trial results.
- History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or having symptoms of QT prolongation syndrome and a family history (indicated by genetic evidence or sudden cardiac death of close relatives at a young age).
- History of capsular bacterial infection (e.g., Neisseria meningitidis, etc.) within 6 months before screening.
- History of tuberculosis infection or currently suffering from tuberculosis.
- Underwent major surgery within 6 months before screening or surgical incision not healed (excluding healed appendicitis and rectal prolapse surgeries).
- Severely allergic, allergic to trial drugs/excipients, two or more other drugs/foods, or having special diet requirements and unable to follow a unified diet.
- Having hemorrhoids or perianal diseases with regular/ongoing rectal bleeding, irritable bowel syndrome, or inflammatory bowel disease.
- Alcoholism or regular drinking (> 14 alcohol units/week) within 6 months before screening, or positive alcohol breath test.
- Smoking more than 5 cigarettes per day or habitually using nicotine - containing products within 3 months before the screening period and being unable to quit during the trial.
- Having drug abuse or dependence, with a positive urine drug abuse screening.
- Habitually drinking grapefruit juice or excessive tea (more than 8 cups a day, 1 cup = 250 mL), or excessive caffeine intake (more than 3 cups of coffee a day, etc.) and being unable to quit during the trial.
- Long - term exposure to radiation at work, or significant radiation exposure (≥ 2 chest/abd CT or ≥ 3 other X - rays) within 1 year before the trial, or participated in a radiopharmaceutical trial within 1 year.
- Received a live vaccine within 1 month before screening or planned to during the trial.
- History of fainting at the sight of needles/blood, difficult blood collection, or intolerance to venipuncture.
- Fertility plan during the trial and within 1 year after the last dose, or disagreed to take strict contraceptive measures.
- Blood loss or donation ≥ 400 mL within 3 months before screening, or received a blood transfusion within 1 month.
- For any reason subject is considered by the investigator to be an unsuitable candidate.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
About this study
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HSK39297
Read the detailed description
- To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]HHSK39297 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways
- To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of [14C]HSK39297, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma
- To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of [14C]HSK39297 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways
- Being tested
- Carbon-14 labeled HSK39297
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon-14 labeled HSK39297Drug
Dose A
| Study group | Role | What they receive |
|---|---|---|
| [14C]HSK39297 | Experimental | Not described Receives: Drug: Carbon-14 labeled HSK39297 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of total radioactivity in urine and fecal samples
Mass balance recovery of total radioactivity in urine and fecal samples
Measured: Up to 312 hours post dose
Total radioactivity in plasma PK
PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points.
Measured: Up to 312 hours post dose.
Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples
Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites
Measured: Up to 312 hours post dose.
Secondary outcomes (1)
Number of participants with adverse events
All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and ophthalmological assessments
Measured: Up to 312 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start9 Sep 2024
- Primary completion27 Sep 2024
- Study completion10 Dec 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 (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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
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
- NCT06852092
- Sponsor's protocol ID
- HSK39297-102
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT06852092
- Acronym / sponsor ID
- HSK39297-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 28 Feb 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.
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HSK39297
Detailed description
- To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]HHSK39297 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways
- To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of [14C]HSK39297, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma
- To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of [14C]HSK39297 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]HSK39297 | Experimental | Drug: Carbon-14 labeled HSK39297 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese healthy male subjects aged between 18 and 45 years old (inclusive, at the time of signing the informed consent form);
- Body weight ≥ 50 kg and body mass index (BMI) within the range of 19 - 26 kg/m² (inclusive);
- Capable of comprehending the procedures and methodologies of this study, disposed to strictly adhere to the related requirements of the protocol, and capable of signing the informed consent form.
Key exclusion criteria (24 listed)
- Abnormal and clinically significant findings in physical examination, vital signs, laboratory tests (blood routine, biochemistry, coagulation function, urine routine, stool routine + fecal occult blood, thyroid function), ophthalmic examination (slit lamp, intraocular pressure, fundus photography), 12 - lead electrocardiogram [QT interval corrected by Fridericia method (QTcF), 350 - 450 ms (inclusive) for men], X - ray chest film (anterior - posterior and lateral views), abdominal B - ultrasound (liver, gallbladder, pancreas, spleen), urinary system B - ultrasound (kidneys, ureters, bladder, prostate), etc.
- Positive for hepatitis B surface antigen, hepatitis C virus IgG antibody, human immunodeficiency virus antibody and antigen p24, and Treponema pallidum antibody.
- Use of prescription drugs, over - the - counter drugs, or health care products, including Chinese patent medicine, within 14 days before the screening period or within 5 half - lives of the drug (whichever is longer).
- Participated in a clinical trial and received investigational drugs or devices within 3 months before screening.
- Use of any drugs that inhibit or induce the activity of liver drug - metabolizing enzymes or P - gp inhibitors within 30 days before screening.
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 |
|---|---|---|
| Carbon-14 labeled HSK39297Dose A | Drug | [14C]HSK39297 |
Primary outcome
Recovery of total radioactivity in urine and fecal samples
Time frame: Up to 312 hours post dose
Mass balance recovery of total radioactivity in urine and fecal samples
Total radioactivity in plasma PK
Time frame: Up to 312 hours post dose.
PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points.
Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples
Time frame: Up to 312 hours post dose.
Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 312 hours post dose.
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 28 Feb 2025.
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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 Carbon-14 labeled HSK39297 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 3 inclusion and 24 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 28 Feb 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?
Recovery of total radioactivity in urine and fecal samples (time frame: Up to 312 hours post dose). 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 28 Feb 2025.