Healthy ParticipantsPhase 1NCT07535970
A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants
A Phase 1 study testing HS-10506, Itraconazole in people with Healthy Participants, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- HS-10506, Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Jul 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the trial regulations;
- Adult males and females (aged between 18 and 45 years, inclusive of boundary values, calculated on the date of signing the informed consent form);
- Participant's Body Mass Index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive of boundary values); male participants weigh ≥ 50 kg, female participants weigh ≥ 45 kg;
- Agree to practice highly effective contraception from the signing of the informed consent form until 3 months after the last dose, and have no plans for pregnancy or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the trial).
Who cannot join
- Those with clinically significant abnormalities in physical examination, vital signs, oxygen saturation, 12-lead electrocardiogram, clinical laboratory tests, etc., deemed by the investigator as unsuitable for enrollment;
- Positive results for any one or more of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum(TP)specific antibody during the screening period;
- 12-lead electrocardiogram results during the screening period showing QTcF>450.00 ms for males or QTcF>470.00 ms for females;
- Previous or current presence of severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., anatomical abnormalities of the airway, congenital microstomia with macroglossia, mandibular hypoplasia; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system, endocrine and metabolic system, immune system, hematological system, etc., assessed by the investigator as unsuitable for participation in this study;
- Current or past history of psychiatric disorders or brain dysfunction, or assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS), or self-injurious behavior or suicide attempt within one year before screening, or current suicide risk based on the investigator's clinical judgment;
- Current or past history of severe gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, reflux esophagitis, etc.);
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- Evidence of previous ventricular dysfunction, such as congestive heart failure (CHF)or a history of CHF;
- History of surgery within 3 months before screening, or planned surgery during the trial period, or surgery that may affect drug absorption, distribution, metabolism, or excretion, deemed by the investigator as unsuitable for enrollment;
- Participation in any other clinical trial involving any investigational drug or device within 3 months before screening, or within 7 half-lives of another investigational drug before screening, whichever is longer;
- Prone to allergic reactions, or allergic constitution(e.g., allergies to pollen, two or more drugs/foods), or known allergy to components of HS-10506 tablets or itraconazole capsules;
- History of drug abuse, drug dependence, or use of illicit drugs within 5 years before screening, or positive drug abuse screening results;
- Frequent alcohol consumption within 3 months before screening (i.e., consuming more than 14 units of alcohol per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine, equivalent to 10 bottles of beer, 500 mL spirits, or 3 bottles of wine per week), or inability to stop consuming alcoholic products during the trial, or positive alcohol breath test;
- Average daily smoking of more than 5 cigarettes within 3 months before screening, or inability to stop using any tobacco products during the trial;
- Excessive consumption of tea, coffee, and/or caffeinated beverages within 3 months before screening (average of more than 8 cups per day; 1 cup = 200 mL);
- Significant blood loss(≥200 mL)or blood donation within 3 months before screening, or plans for blood donation during the study or within 3 months after the study;
- Use of any drugs affecting CYP3A, CYP2C19 enzymes, or drugs altering gastric acid [proton pump inhibitors (PPIs), H2 receptor antagonists, topical antacids, oral alkaline drugs, etc.] within 30 days before the first dose of investigational product(or within 7 times the corresponding elimination half-life, whichever is longer);
- Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements(excluding topical preparations with local effects) within 14 days before the first dose of investigational product, or use of any drug within 7 half-lives (whichever is longer);
- Consumption of grapefruit or grapefruit products within 48 hours before the first dose of investigational product;
- Vaccination within 30 days before the first dose of investigational product, or planned use of vaccines during the study or within two weeks after the study;
- Significant changes in diet or sleep habits within 4 weeks before screening, assessed by the investigator as unsuitable for participation in this study;
- Female participants who are pregnant, breastfeeding, or have a positive pregnancy test result within 1 month before screening or during the trial period;
- Unprotected sexual intercourse within 14 days before screening;
- Special dietary requirements, inability to comply with a unified diet, or difficulty swallowing;
- Intolerance to venipuncture/indwelling needle blood collection or fear of needles/blood;
- Inability to complete the study for other reasons or deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.
Read the detailed description
On Day 1 and Day 11 of the trial, HS-10506 tablets will be orally administered under fasting conditions in the morning. From Day 7 to Day 15, itraconazole capsules (0.2 g, administered as two 0.1 g capsules) will be taken orally once daily for nine consecutive days. On the morning of Day 11, itraconazole capsules and HS-10506 tablets will be taken concurrently. When administered alone or in combination with itraconazole capsules, HS-10506 tablets will be given under fasting conditions. When administered alone, itraconazole capsules will be taken within 15 minutes after a meal, with approximately 240 mL of water.
- Conditions
- Healthy Participants
- Being tested
- HS-10506, Itraconazole
- Keywords
- Phase 1, Drug interaction, Itraconazole, HS-10506, Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10506, ItraconazoleDrug
HS-10506: Administered under fasting conditions in the morning. Itraconazole: Itraconazole capsules (0.2 g) are taken orally once daily for nine consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Drug-drug interaction Arm Receives: Drug: HS-10506, Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of PK parameters of HS-10506: Cmax
To evaluate the Cmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: AUC0-t
To evaluate the AUC0-t of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: AUC0-∞
To evaluate the AUC0-∞ of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Secondary outcomes (19)
Evaluation of PK parameters of HS-10506:Tmax
To evaluate the Tmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: t1/2z
To evaluate the t1/2z of HS-10506 administered alone and in combination with Itraconazole in healthy participants
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: λz
To evaluate the λz of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: CL/F
To evaluate the CL/F of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: Vz/F
To evaluate the Vz/F of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: MRT0-t
To evaluate the MRT0-t of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: MRT0-∞
To evaluate the MRT0-∞ of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: 120 hours after administration of HS-10506
Adverse events
To evaluate the adverse events (AEs) of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
blood pressure
To evaluate the blood pressure of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
Pulse
To evaluate the Pulse of HS-10506 administered alone and in combination with Itraconazole in healthy participants
Measured: through study completion, an average of 36 days
body temperature
To evaluate the body temperature of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
oxygen saturation
To evaluate the oxygen saturation of HS-10506 administered alone and in combination with Itraconazole in healthy participants
Measured: through study completion, an average of 36 days
complete blood count (CBC)
To evaluate the abnormal of complete blood count (CBC)of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
urinalysis
To evaluate the abnormal of urinalysis of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
blood chemistry
To evaluate the abnormal of blood chemistry of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
coagulation tests
To evaluate the abnormal of coagulation tests of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
thyroid function test (TFT)
To evaluate the abnormal of thyroid function test (TFT) of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
Physical examination (include skin, mucous membranes and lymph nodes; head and neck; chest; abdomen; spine and extremities; nervous system, etc)
To evaluate the abnormal of physical examination of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
12-lead electrocardiogram (include heart rate, PR, RR, QRS duration, QT interval and QTcF)
To evaluate the abnormal of 12-lead electrocardiogram of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Measured: through study completion, an average of 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535970
- Sponsor's protocol ID
- HS-10506-113
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2026
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants
- ClinicalTrials.gov ID
- NCT07535970
- Acronym / sponsor ID
- HS-10506-113
- Conditions
- Healthy Participants
- Keywords
- Phase 1, Drug interaction, Itraconazole, HS-10506, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 17 Apr 2026 (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.
A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.
Detailed description
On Day 1 and Day 11 of the trial, HS-10506 tablets will be orally administered under fasting conditions in the morning. From Day 7 to Day 15, itraconazole capsules (0.2 g, administered as two 0.1 g capsules) will be taken orally once daily for nine consecutive days. On the morning of Day 11, itraconazole capsules and HS-10506 tablets will be taken concurrently. When administered alone or in combination with itraconazole capsules, HS-10506 tablets will be given under fasting conditions. When administered alone, itraconazole capsules will be taken within 15 minutes after a meal, with approximately 240 mL of water.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: HS-10506, ItraconazoleDrug-drug interaction Arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the trial regulations;
- Adult males and females (aged between 18 and 45 years, inclusive of boundary values, calculated on the date of signing the informed consent form);
- Participant's Body Mass Index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive of boundary values); male participants weigh ≥ 50 kg, female participants weigh ≥ 45 kg;
- Agree to practice highly effective contraception from the signing of the informed consent form until 3 months after the last dose, and have no plans for pregnancy or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the trial).
Key exclusion criteria (25 listed)
- Those with clinically significant abnormalities in physical examination, vital signs, oxygen saturation, 12-lead electrocardiogram, clinical laboratory tests, etc., deemed by the investigator as unsuitable for enrollment;
- Positive results for any one or more of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum(TP)specific antibody during the screening period;
- 12-lead electrocardiogram results during the screening period showing QTcF>450.00 ms for males or QTcF>470.00 ms for females;
- Previous or current presence of severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., anatomical abnormalities of the airway, congenital microstomia with macroglossia, mandibular hypoplasia; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system, endocrine and metabolic system, immune system, hematological system, etc., assessed by the investigator as unsuitable for participation in this study;
- Current or past history of psychiatric disorders or brain dysfunction, or assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS), or self-injurious behavior or suicide attempt within one year before screening, or current suicide risk based on the investigator's clinical judgment;
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 |
|---|---|---|
| HS-10506, ItraconazoleHS-10506: Administered under fasting conditions in the morning. Itraconazole: Itraconazole capsules (0.2 g) are taken orally once daily for nine consecutive days. | Drug | Experimental group |
Primary outcome
Evaluation of PK parameters of HS-10506: Cmax
Time frame: 120 hours after administration of HS-10506
To evaluate the Cmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Evaluation of PK parameters of HS-10506: AUC0-t
Time frame: 120 hours after administration of HS-10506
To evaluate the AUC0-t of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Evaluation of PK parameters of HS-10506: AUC0-∞
Time frame: 120 hours after administration of HS-10506
To evaluate the AUC0-∞ of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
19 secondary outcomes
Evaluation of PK parameters of HS-10506:Tmax
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: t1/2z
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: λz
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: CL/F
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: Vz/F
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: MRT0-t
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: MRT0-∞
Time frame: 120 hours after administration of HS-10506
Adverse events
Time frame: through study completion, an average of 36 days
blood pressure
Time frame: through study completion, an average of 36 days
Pulse
Time frame: through study completion, an average of 36 days
body temperature
Time frame: through study completion, an average of 36 days
oxygen saturation
Time frame: through study completion, an average of 36 days
complete blood count (CBC)
Time frame: through study completion, an average of 36 days
urinalysis
Time frame: through study completion, an average of 36 days
blood chemistry
Time frame: through study completion, an average of 36 days
coagulation tests
Time frame: through study completion, an average of 36 days
thyroid function test (TFT)
Time frame: through study completion, an average of 36 days
Physical examination (include skin, mucous membranes and lymph nodes; head and neck; chest; abdomen; spine and extremities; nervous system, etc)
Time frame: through study completion, an average of 36 days
12-lead electrocardiogram (include heart rate, PR, RR, QRS duration, QT interval and QTcF)
Time frame: through study completion, an average of 36 days
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 17 Apr 2026.
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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 HS-10506, Itraconazole in people with Healthy Participants, run by Jiangsu Hansoh Pharmaceutical 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 4 inclusion and 25 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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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 Wei Zhao, Doctor (0531-82169023, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of PK parameters of HS-10506: Cmax (time frame: 120 hours after administration of HS-10506). 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 17 Apr 2026.