To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers

Inclusion criteria

Single ascending dose (SAD), Multiple ascending dose (MAD) and Food Effect Parts:

• Healthy male volunteers
• Subject's age is no less than 20 years old
• Subjects whose body mass index (BMI) at screening is within a range of ≥18.5 kg/m2 and <25.0 kg/m2.

BMI = Body Weight (kg) / [Height (m)]2 Body weight is not less than 50 kg

• Subjects who are judged to be in good health by the investigator based upon the results of physical examinations, chest X-ray (within 180 days prior to the first dose of the study) and routine laboratory tests.
• Subjects did not take any of the following medications in the specified durations:

• Any systemically-absorbed medication (excluding vitamins, food supplements, and hormone contraceptives for birth control) within 14 days prior to the first dose of the study
• Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, troleandomycin, ketoconazole, miconazolem fluconazole, itraconazole) within 30 days prior to the first dose of the study
• Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form.

Extra Criteria for the MAD and Food Effect Parts

• Healthy female volunteers whose body weight is not less than 45 kg
• Female subjects show negative pregnancy test results within 30 days prior to the first study dose.
• Female subjects of child-bearing potential, committing to practicing sexual abstinence or using and continue to use a medically acceptable form of birth control for at least 1 month prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above.

Extra Criteria for the MAD Part

• Subjects who are self-reporting current smokers (>10 pack/years).

Exclusion criteria

SAD, MAD and Food Effect Parts:

• Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
• Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed >90 days prior to the first dose of the study
• Subjects had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.
• Subjects had blood donation of more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.
• Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria.
• Subject's medical history shows contraindications or hypersensitivity to the use of test medications [HL0 or any component of drug products].
• Subjects who have been tested positive for the following tests:

• Human immunodeficiency virus (HIV)
• Hepatitis B virus (HBV)
• Hepatitis C virus (HCV)
• Subjects who cannot stop caffeine-intake for 48 hours prior to the first study dose and during the entire study period.
• Subjects with underlying medical, mental or psychological conditions that would impair treatment compliance, or in the opinion of the investigator would not permit to participate in the study
• Subjects who have received or are taking any medications that may interfere the assessment [e.g., anti-inflammatories, anti-asthma/COPD (chronic obstructive pulmonary disease) and anti-IPF (idiopathic pulmonary fibrosis) medications] for a period of up to 14 days prior to the first dose of the study Extra Criteria for the MAD and Food Effect Parts
• Female subjects who are lactating Extra criteria for the MAD part
• Subjects who did not smoke for more than 2 days prior to the first dose of the study or during the study period