Healthy ParticipantsPhase 1NCT07764692
A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504
A Phase 1 study testing HS-10504 and Itraconazole Capsules in people with Healthy Participants, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- HS-10504 and Itraconazole Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Mar 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form prior to the study, fully understand the study content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the protocol;
- Adult male and female participants (aged ≥18 years, calculated on the day of signing the informed consent form);
- Agree to practice highly effective contraception from the signing of the informed consent form until 6 months after the last dose of HS-10504 and have no plans for reproduction or sperm/egg donation during this period.
Who cannot join
- Subjects with clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, chest X-ray (posteroanterior and lateral views), clinical laboratory tests, abdominal and renal ultrasound, etc., during the screening period, which are deemed unsuitable for enrollment by the investigator.
- Subjects with a history of severe diseases of the nervous, psychiatric, digestive, circulatory, respiratory, or urinary systems, or currently having such diseases, or newly diagnosed diseases before administration of the investigational product, which are assessed by the investigator as unsuitable for participation in this trial.
- Subjects who have had surgery within 3 months prior to screening, or have planned surgery during the trial, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion, and are deemed unsuitable for enrollment by the investigator.
- Subjects who have participated in any other clinical trial and received any investigational drug/device within 3 months prior to screening.
- Subjects with a history of severe allergies, or allergic constitution, or known allergy to any component of the investigational product, or a history of hypersensitivity to drugs with chemical structures similar to HS-10504 or belonging to the same class as HS-10504.
- Subjects with a history of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or those with a positive result in drug abuse screening.
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- Subjects who are habitual drinkers within 3 months prior to screening, or those who cannot abstain from alcohol during the trial, or those with a positive breath alcohol test during screening.
- Subjects who have smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or those who cannot refrain from using any tobacco products during the trial.
- Subjects who have consumed excessive amounts of tea, coffee, or caffeinated beverages within 3 months prior to screening.
- Subjects who have had significant blood loss (≥400 mL) or donated blood within 3 months prior to screening, or donated blood or lost blood ≥200 mL within 1 month, or those who plan to donate blood during the trial.
- Subjects who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (excluding topical agents with local effects) within 30 days prior to the first dose of the investigational product, or who have used any drug within a period less than 7 half-lives (whichever is longer) before dosing.
- Subjects who are lactating within 1 month prior to screening or during the trial, or female participants with a positive pregnancy test, or those who have had unprotected sexual intercourse within 14 days prior to screening.
- Subjects with special dietary requirements, unable to comply with the unified diet, or with dysphagia.
- Subjects who cannot tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia.
- Subjects who may be unable to complete the trial for other reasons or are deemed unsuitable for participation by the investigator.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504 in Healthy Participants
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
- Conditions
- Healthy Participants
- Being tested
- HS-10504, Itraconazole Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10504Drug
Participants will receive a single oral dose of 400 mg HS-10504 tablets on study days D1 and D15, respectively。
Itraconazole CapsulesDrug
Participants will receive itraconazole capsules 0.2 g orally once daily from Day 11 to Day 23 for 13 consecutive days (with co-administration of itraconazole and HS-10504 on an empty stomach on Day 15)。
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Drug-drug interaction Arm Receives: Drug: HS-10504; Drug: Itraconazole Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of PK parameters of HS-10504 and M6-2: Cmax
To evaluate the Cmax of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and M6-2: AUC0-t
To evaluate the AUC0-t of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and M6-2:AUC0-∞
To evaluate the AUC0-∞ of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Measured: 216 hours after administration of HS-10504
Secondary outcomes (4)
Evaluation of PK parameters of HS-10504 and M6-2: Tmax
To evaluate the Tmax of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and M6-2: t1/2z
To evaluate the t1/2z of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and M6-2: λz
To evaluate the λz of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Measured: 216 hours after administration of HS-10504
Adverse events
To evaluate the vital signs of HS-10504 administered alone and in combination with itraconazole
Measured: Up to end of the study, approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Mar 2027 (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
- 8 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
- NCT07764692
- Sponsor's protocol ID
- HS-10504-112
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07764692
- Acronym / sponsor ID
- HS-10504-112
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Aug 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.
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
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-10504, Drug: Itraconazole CapsulesDrug-drug interaction Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily sign the informed consent form prior to the study, fully understand the study content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the protocol;
- Adult male and female participants (aged ≥18 years, calculated on the day of signing the informed consent form);
- Agree to practice highly effective contraception from the signing of the informed consent form until 6 months after the last dose of HS-10504 and have no plans for reproduction or sperm/egg donation during this period.
Key exclusion criteria (15 listed)
- Subjects with clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, chest X-ray (posteroanterior and lateral views), clinical laboratory tests, abdominal and renal ultrasound, etc., during the screening period, which are deemed unsuitable for enrollment by the investigator.
- Subjects with a history of severe diseases of the nervous, psychiatric, digestive, circulatory, respiratory, or urinary systems, or currently having such diseases, or newly diagnosed diseases before administration of the investigational product, which are assessed by the investigator as unsuitable for participation in this trial.
- Subjects who have had surgery within 3 months prior to screening, or have planned surgery during the trial, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion, and are deemed unsuitable for enrollment by the investigator.
- Subjects who have participated in any other clinical trial and received any investigational drug/device within 3 months prior to screening.
- Subjects with a history of severe allergies, or allergic constitution, or known allergy to any component of the investigational product, or a history of hypersensitivity to drugs with chemical structures similar to HS-10504 or belonging to the same class as HS-10504.
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-10504Participants will receive a single oral dose of 400 mg HS-10504 tablets on study days D1 and D15, respectively。 | Drug | Experimental group |
| Itraconazole CapsulesParticipants will receive itraconazole capsules 0.2 g orally once daily from Day 11 to Day 23 for 13 consecutive days (with co-administration of itraconazole and HS-10504 on an empty stomach on Day 15)。 | Drug | Experimental group |
Primary outcome
Evaluation of PK parameters of HS-10504 and M6-2: Cmax
Time frame: 216 hours after administration of HS-10504
To evaluate the Cmax of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Evaluation of PK parameters of HS-10504 and M6-2: AUC0-t
Time frame: 216 hours after administration of HS-10504
To evaluate the AUC0-t of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
Evaluation of PK parameters of HS-10504 and M6-2:AUC0-∞
Time frame: 216 hours after administration of HS-10504
To evaluate the AUC0-∞ of HS-10504 and M6-2 of HS-10504 administered alone and in combination with itraconazole
4 secondary outcomes
Evaluation of PK parameters of HS-10504 and M6-2: Tmax
Time frame: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and M6-2: t1/2z
Time frame: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and M6-2: λz
Time frame: 216 hours after administration of HS-10504
Adverse events
Time frame: Up to end of the study, approximately 8 months
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 14 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10504 and Itraconazole Capsules in people with Healthy Participants, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
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 15 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Evaluation of PK parameters of HS-10504 and M6-2: Cmax (time frame: 216 hours after administration of HS-10504). 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 14 Aug 2026.