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A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504

NCT07764692 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

HS-10504

Participants will receive a single oral dose of 400 mg HS-10504 tablets on study days D1 and D15, respectively。

DRUG

Itraconazole Capsules

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)。

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-03-01
Completion
2027-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764692 on ClinicalTrials.gov