A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 in Healthy Participants

Exclusion Criteria11

• History of allergic diseases, or known allergy to the investigational product, its excipients, or related products.
• History of significant cardiovascular, respiratory, renal, neurological disease.
• History of psychiatric disorders, substance abuse, or drug dependence.
• Suicidal risk according to the Columbia-Suicide Severity Rating Scale (C-SSRS) or based on the investigator's clinical judgment, or history of self-injurious behavior.
• Smoking ≥5 cigarettes per day within 3 months prior to screening.
• Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements within 14 days prior to the first dose.
• Participation in another clinical trial and receipt of an investigational drug within 3 months prior to the first dose.
• Blood donation or significant blood loss (>400 mL) or blood transfusion within 3 months prior to the first dose.
• Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody.
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant.
• Pregnant or lactating females or subjects (including males) planning to father a child during the trial or within 3 months after the last dose, unwillingness to use effective non-pharmacological contraception during the trial period.