NCT07650383已完成1 期
A Phase I, Double-Blinded, Randomized, Vehicle-Controlled, and Single-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ENERGI-F705 Tablets in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
To evaluate the safety, the tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of ENERGI-F705 Tablets in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All genders aged ≧18 to < 45 years.
- •Able to understand and sign informed consent form.
- •Able to communicate well with the Investigator and comply with the requirements of the study.
- •Body mass index (BMI) ranged 18.5≦BMI < 27 kg/m2 .
- •Males weighting ≧50 kg and females weighting ≧45 kg.
- •Healthy subjects as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, chest X-ray, and clinical laboratory evaluations.
- •Is willing to follow the study life style instruction and protocol procedure
- •Negative test for human immunodeficiency virus (HIV), syphilis, hepatitis B virus surface antigen (HBsAg), and anti-HCV antibody at screening.
排除标准
- •History of adverse reactions or allergy of active ingredient, components in IP or related products.
- •Significant drug abuse.
- •Having any medical history as judged by the Investigator (including but not limited to neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorders).
- •Presence of significant neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, renal, or other pathology, as judged by the Investigator.
- •Pregnant or lactating women.
- •Having an acute illness or surgery within 4 weeks prior to dosing.
- •Other conditions not suitable for participating in this study as judged by the Investigator.
- •History of cancer (malignancy) or have ever received any anti-cancer therapy.
- •Taking any prescription, vaccine, herbal products or over-the-counter (OTC) medication, including antacids, calcium, other supplements and vitamins, that may interfere with the safety or PK/PD assessment judged by the Investigator within 14 days prior to dosing.
- •Joining any drug clinical trial within 2 months prior to dosing.
- •Blood loss/donation of ≧250 mL within 2 months or blood loss/donation of ≧500 mL within 3 months prior to dosing.
- •Healthy adult subjects or subjects' active sexual partners disagree to use at least one form of highly effective contraceptive methods during the study period and for 5 half-lives of active ingredient plus 90 days (94 days in total) after dosing. During this time, sperm or egg donation is prohibited while contraceptive methods are in use.
- •Acceptable forms of highly effective contraceptive methods for female subjects include:
- •Surgically sterile (documented hysterectomy, documented bilateral salpingectomy, bilateral oophorectomy)
- •Placement of an intrauterine device (IUD) in conjunction with a barrier method (use of condom by the male partner)
- •Total sexual abstinence
- •Acceptable forms of highly effective contraceptive methods for male subjects include:
- •Surgically sterile (vasectomy with documented negative semen analysis)
- •Condom in conjunction with an IUD (used by the female partner)
- •Condom in conjunction with oral/implantable/injectable contraceptives (used by the female partner)
- •Total sexual abstinence
- •Having a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •The result of AST or ALT >2 times the upper limit of normal or presence of clinically significant abnormality, as judged by the Investigator.
- •The result of creatinine is abnormal or eGFR < 90 mL/min/1.73 m2 or presence of clinically significant abnormality, as judged by the Investigator.
- •Presence of, history of, or suspected gout, hyperuricemia or urolithiasis, as judged by the Investigator.
- •Clinically significant ECG abnormality at screening.
- •Presence of risk for QT prolongation, as judged by the Investigator.
- •Regular smoker.
- •Regular smoker is defined as who smokes every day (≥ 1 cigarette/day in average in the past 8 weeks of Screening)
- •Consumed greater than 3 units of alcoholic beverages per day in average for the past 4 weeks prior to dosing.
- •One unit is equivalent to one can of beer (<10% alcohol; about 330 mL), one glass of wine (10~20% alcohol; about 150 mL), or one shot of distilled spirits (>20% alcohol; about 45 mL)
研究组 & 干预措施
ENERGI-F705 60 mg
Active Comparator
干预措施: ENERGI-F705 Tablets 60 mg (Drug)
ENERGI-F705 120 mg
Active Comparator
干预措施: ENERGI-F705 Tablets 120 mg (Drug)
Vehicle Control
Placebo Comparator
干预措施: Vehicle Control (Drug)
结局指标
主要结局
Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs)
时间窗: From dosing through end of study (approximately 4 days post-dose)
Number and percentage of subjects with treatment-emergent adverse events (TEAEs).
次要结局
- Maximum Observed Whole Blood Concentration (Cmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration(From pre-dose to 72 hours post-dose)
- Time to Maximum Observed Whole Blood Concentration (Tmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration(From pre-dose to 72 hours post-dose)
- Trough Whole Blood Concentration (Ctrough) of ENERGI-F705 and Its Metabolite at 72 Hours Following Single Oral Administration(From pre-dose to 72 hours post-dose)
- Area Under the Whole Blood Concentration-Time Curve (AUC) of ENERGI-F705 and Its Metabolite Following Single Oral Administration(From pre-dose to 72 hours post-dose)
- Terminal Elimination Half-life (T½) of ENERGI-F705 and Its Metabolite Following Single Oral Administration(From pre-dose to 72 hours post-dose)
- Apparent Total Body Clearance (CL/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration(From pre-dose to 72 hours post-dose)
- Apparent Volume of Distribution (Vd/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration(From pre-dose to 72 hours post-dose)
- Whole Blood Adenosine Triphosphate (ATP) Level Following Single Oral Administration of ENERGI-F705 Tablets(From pre-dose to 72 hours post-dose)
研究者
研究点 (1)
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