NCT06350279已完成1 期
A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年12月25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
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The number and severity of treatment emergent adverse events (TEAEs) .
研究概览
简要总结
This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
- •18 years to 45 years (inclusive), male and female;
- •Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-26 kg/m2 (inclusive) ;
- •Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
排除标准
- •Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
- •Have an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;
- •Have a clear history of capsular bacteria infection within 6 months before screening, inncluding but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae B, etc.;
- •Have a history of TB infection or are currently infected with TB;
- •Have a history of any malignant tumors;
- •The abnormalities were clinically significant during the screening period, such as physical examination, vital signs, blood biochemistry, blood routine, coagulation, urine routine, blood pregnancy test, infectious diseases and X-ray;
- •Subjects whose results of routine 12-lead electrocardiograms were inconsistent with normal heart conduction and function;
- •Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
- •Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study;
- •Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening;
- •Have a history of drug abuse prior to screening, or positive urine drug screen at screening;
- •Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration;
- •Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;
- •Subjects who have a allergic to any component of HSK30297 or allergic history to opiates;
- •Any drug that inhibits or induces drug metabolism enzymes or P-gp inhibitor have been administered within 28 days prior to initial administration of the investigational drug;
- •Subjects who use any live vaccine within 30 days prior to screening;
- •Have participated in any clinical investigator within 3 months prior to screening;
- •A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
- •Not suitable for this study as judged by the investigator.
研究组 & 干预措施
HSK39297
Experimental
Single or multiple oral doses of HSK39297
干预措施: HSK39297 (Drug)
Placebo
Experimental
Placebo
干预措施: HSK39297 (Drug)
结局指标
主要结局
The number and severity of treatment emergent adverse events (TEAEs) .
时间窗: 9 days after single dose and 16 days after the first dose of multiple doses
To assess the safety and tolerability of single or multiple oral dose of HSK39297 in healthy adult volunteers
次要结局
- t1/2(Pre-dose to 168 hours post-dose)
- AP change(Pre-dose to 168 hours post-dose)
- Cmax(Pre-dose to 168 hours post-dose)
- AUC(Pre-dose to 168 hours post-dose)
- Tmax(Pre-dose to 168 hours post-dose)
- Bb(Pre-dose to 168 hours post-dose)
研究者
研究点 (1)
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