A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017

Korábbi kezelés

• Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
• Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
• Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
• Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.
• Subject who has participated in other clinical trials within 3 months before administration.

Más betegség

• Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.
• Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
• Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).
• Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.
• Subject has a history of substance abuse within 1 year or a positive urine drug screen.
• Subject who has a history of needle or blood faintness.
• Poor compliance or other conditions which would make participation in the study unsuitable.

Laborértékek

• Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as Pulse < 55 beats/min or > 100 beats/min, Systolic blood pressure < 90 mmHg or ≥140 mmHg, Diastolic blood pressure < 60 mmHg or ≥90 mmHg.
  • QT interval (QTc) ≥450 ms (Male) or 460 ms (Female) .

Egyéb

• Subject who has daily smoking of ≥ 5 cigarettes within 3 months.
• Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.
• Subject has used blood products or being blood donor or blood loss within 3 months.
• Pregnant, lactating women, or positive pregnancy test.
• Subject who refusal to contraception, or plan to donate sperm or ovums.
• Subject directly involved in this clinical trial.

• Subject who voluntarily participate and sign the informed consent form.
• Healthy male/female volunteers aged ≥18 and ≤ 45 years.
• Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 28.0 kg/m2.
• Able to comply with the lifestyle restrictions.