A Study to Evaluate ENERGI-F705 Tablets in Healthy Volunteers

Inclusion criteria

• 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.

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Exclusion criteria

• 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)