A Phase I Clinical Trial to Evaluate Pharmacokinetics of HS-10504

ConditionHealthy Participants

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 pratice 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.

Disqualifiers

Subjects with clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, chest X-ray (posteroanterior and lateral views), clinical laboratory tests, 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.

Trial design

Design model

Single group

Treatments tested in this trial

HS-10504
Drug
Participants will receive a single oral dose of 400 mg HS-10504 tablets on study days D1 and D17, respectively
Rifampin
Drug
articipants will receive Rifampin capsules 600 mg orally once daily on an empty stomach from Day 10 to Day 24 for 15 consecutive days

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: Experimental groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Evaluation of Cmax

o evaluate the Cmax of HS-10504 and M6-2 of HS-10504 administered alone and in combination with Rifampin

Time frame