Can a common antifungal change how an experimental drug acts?
NCT ID NCT07764692
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This Phase 1 trial is investigating whether itraconazole, an antifungal drug, affects the levels of an experimental drug called HS-10504 in the body. Healthy adult volunteers will receive HS-10504 alone and then again while taking itraconazole, allowing researchers to compare how the drug is absorbed and cleared. The goal is to understand potential drug interactions and inform future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS-10504 (an experimental drug) and itraconazole (an antifungal medication)
- What this could lead to
- If itraconazole alters HS-10504 levels, this could guide dosing adjustments for future studies of HS-10504.
- What could go wrong
- This is a small, early-stage study in healthy people, not patients, so results may not predict effects in disease states. Drug interactions may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 2. Adult male and female participants (aged ≥18 years, calculated on the day of signing the informed consent form); 3. 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Subjects who have participated in any other clinical trial and received any investigational drug/device within 3 months prior to screening. 5. 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. 6. 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. 7. 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. 8. 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. 9. Subjects who have consumed excessive amounts of tea, coffee, or caffeinated beverages within 3 months prior to screening. 10. 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. 11. 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. 12. 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. 13. Subjects with special dietary requirements, unable to comply with the unified diet, or with dysphagia. 14. Subjects who cannot tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia. 15. Subjects who may be unable to complete the trial for other reasons or are deemed unsuitable for participation by the investigator.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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