NCT07764692尚未招募1 期
A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504 in Healthy Participants
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 8 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 主要终点
- Evaluation of PK parameters of HS-10504 and M6-2: Cmax
研究概览
简要总结
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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-
- •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.
- •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.
研究组 & 干预措施
Experimental group
Experimental
Drug-drug interaction Arm
干预措施: HS-10504 (Drug)
Experimental group
Experimental
Drug-drug interaction Arm
干预措施: Itraconazole Capsules (Drug)
结局指标
主要结局
Evaluation of PK parameters of HS-10504 and M6-2: Cmax
时间窗: 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
时间窗: 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-∞
时间窗: 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
次要结局
- Evaluation of PK parameters of HS-10504 and M6-2: Tmax(216 hours after administration of HS-10504)
- Evaluation of PK parameters of HS-10504 and M6-2: t1/2z(216 hours after administration of HS-10504)
- Evaluation of PK parameters of HS-10504 and M6-2: λz(216 hours after administration of HS-10504)
- Adverse events(Up to end of the study, approximately 8 months)
研究者
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