AzTrials
AzTrials

Healthy SubjectsPhase 1NCT07134465

Clinical Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HSK31858 in Healthy Subjects

A Phase 1 study testing HSK31858 Tablets and Itraconazole Capsules in people with Healthy Subjects, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-center, open-label, two-period, fixed-sequence clinical study to evaluate the effect of Itraconazole on the pharmacokinetics of HSK31858 in healthy subjects Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
HSK31858 Tablets and Itraconazole Capsules
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
11 Aug 2025to 30 Nov 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

  • Healthy male or female, aged 18 to 45 years (inclusive) at screening;
  • Body weight ≥ 50 kg for males and ≥ 45 kg for females at screening; body mass index (BMI = weight (kg)/height2 (m2)) should be within the range of 19.0-26.0 kg/m2 (inclusive);
  • Subjects (including their partners) agree to have no fertility plan, no sperm or egg donation plans, and take effective non-drug contraceptive measures (including complete abstinence, condoms, intrauterine device, partner sterilization, etc.) during the study and within 3 months after the last dose;
  • Fully understand the purpose, requirements and potential risks of this study, voluntarily participate in the clinical study, and be able to sign the informed consent form (ICF) before the study;

Who cannot join

  • Subjects with a known allergy to HSK31858 tablets, Itraconazole capsules, or any component of similar drugs and preparations, or those with an allergic constitution (e.g., allergies to two or more drugs or food allergies); or those with a history of specific allergies (e.g., asthma, urticaria, eczema, etc.);
  • Subjects who have special dietary requirements and cannot follow a uniform diet (including those with lactose intolerance); or those with dysphagia;
  • Subjects with clinically significant abnormalities in vital signs, physical examination, laboratory tests (blood routine test, blood biochemistry, coagulation function, urinalysis), 12-lead ECG, chest X-ray (anteroposterior), or color ultrasonography, which are inappropriate for participation in this study as judged by the investigator;
  • Subjects who have excessively consumed tea, coffee, or caffeinated beverages (more than 4 cups per day, 1 cup = 250 mL) within 3 months prior to screening; or who have consumed tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours prior to the first dose; or who do not agree to stop consuming tea, coffee or food or beverages containing caffeine during the study;
  • Subjects who have consumed large amounts of grapefruit-rich beverages or food (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days prior to screening; or who have consumed any grapefruit-rich beverages or food within 48 hours prior to the first dose; or who do not agree to stop consuming any grapefruit-rich beverages or food during the study;
  • Subjects with a history or current diagnosis of significant cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune, dermatologic, or neurologic disease, including those who have undergone major surgery within 3 months prior to screening or whose surgical incision has not completely healed;
Show all 20Show fewer
  • Subjects with a history or current diagnosis of gastrointestinal, liver, kidney, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion;
  • Subjects previously diagnosed with periodontitis or/and palmoplantar hyperkeratoses.
  • Subjects who have donated or lost blood ≥ 400 mL within 3 months prior to screening or plan to donate blood during the study, or who have received blood transfusion or used blood products within 3 months prior to screening;
  • Subjects who have used any drug that inhibits or induces hepatic CYP enzymes (e.g., CYP3A4 inducers-rifampicin, dexamethasone, carbamazepine, phenytoin, fosphenytoin, primidone, enzalutamide, St. John's Wort, etc.; CYP3A4 inhibitors-itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, ritonavir, etc.) within 28 days prior to screening or within 5 half-lives of the drug (whichever is longer), or who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine, or health care products other than those listed above within 14 days prior to screening or within 5 half-lives of the drug (whichever is longer);
  • Subjects who have participated in other drug clinical studies within 3 months prior to screening; or who plan to participate in other clinical studies during the study;
  • Subjects who have been vaccinated within 1 month before screening, or who plan to be vaccinated during the study;
  • Subjects with a history of drug addiction, drug abuse, or drug dependence, or who have a positive drug abuse screening at screening;
  • Subjects who have frequently consumed alcohol within 3 months before screening, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or who cannot abstain from alcohol during the study, or who have a positive breath alcohol test at screening;
  • Subjects who have smoked more than 5 cigarettes per day (or equivalent amount of nicotine-containing products) within 3 months prior to screening, or who cannot abstain from smoking during the study;
  • Subjects who are tested positive for one or more of the following at screening: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody;
  • Subjects with a history of needle sickness or blood sickness, difficulty in blood collection, or intolerance to blood collection by venipuncture;
  • Subjects with tattoos or scars on any site of the skin that affect safety assessment as judged by the investigator;
  • Women who are pregnant or breastfeeding; or those with a positive pregnancy test;
  • Subjects who, in the investigator's opinion, have poor compliance or other factors that make them unsuitable for participation in this study.

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

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

Other trials in China

About this study

Official title: A Single-center, Open-label, Two-period, Fixed-sequence Clinical Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HSK31858 in Healthy Subjects

This is a single-center, open-label, two-period, fixed-sequence clinical study to evaluate the effect of Itraconazole on the pharmacokinetics of HSK31858 in healthy subjects

Being tested
HSK31858 Tablets and Itraconazole Capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK31858 Tablets and Itraconazole CapsulesDrug

    HSK31858 Tablets On the morning of Day 1, a single dose of HSK31858 tablets 40 mg will be administered.

    Itraconazole capsules After a 10-day washout period, Take Itraconazole capsules 200mg in the morning and 200mg in the evening on D11 . A single dose of Itraconazole capsules 200 mg will be administered every morning from Day 12 to Day 14. On the morning of Day 15, take a single dose of itraconazole capsules 200mg, followed by a single dose of HSK31858 tablets 40 mg 1 hour later,

Study groups in NCT07134465
Study groupRoleWhat they receive
combination drugExperimentalHSK31858 Tablets and Itraconazole Capsules
Receives: Drug: HSK31858 Tablets and Itraconazole Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    The pharmacokinetic parameters of unchanged HSK31858 in plasma

    Measured: [Time Frame: From the start of administration to 216 hours post-dose]

  2. AUC(0-∞)

    The pharmacokinetic parameters of unchanged HSK31858 in plasma

    Measured: [Time Frame: From the start of administration to 216 hours post-dose]

Secondary outcomes (6)

  1. AUC(0-t)

    The pharmacokinetic parameters of unchanged HSK31858 in plasma

    Measured: [Time Frame: From the start of administration to 216 hours post-dose]

  2. Tmax

    The pharmacokinetic parameters of unchanged HSK31858 in plasma

    Measured: [Time Frame: From the start of administration to 216 hours post-dose]

  3. t1/2

    The pharmacokinetic parameters of unchanged HSK31858 in plasma

    Measured: [Time Frame: From the start of administration to 216 hours post-dose]

  4. Cmax

    The pharmacokinetic parameters of metabolite M4 in plasma

    Measured: [Time Frame: From the start of administration to 216 hours post-dose]

  5. AUC(0-∞)

    The pharmacokinetic parameters of metabolite M4 in plasma

    Measured: [Time Frame: From the start of administration to 216 hours post-dose]

  6. AEs

    The incidence and severity of AEs

    Measured: [Time Frame: From the time of signing ICF to the end of follow-up，up to 30 days]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start11 Aug 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134465
Sponsor's protocol ID
HSK31858-104
Status last verified
Dec 2025
First submitted
14 Aug 2025
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK31858 Tablets and Itraconazole Capsules in people with Healthy Subjects, 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 4 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 31 Dec 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?

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?

Cmax (time frame: [Time Frame: From the start of administration to 216 hours post-dose]). 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?

On the ClinicalTrials.gov record for NCT07134465.

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 31 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in