This study is the first administration of LG-0317 to humans. The purpose of the study is to evaluate safety/tolerability and pharmacokinetics in healthy subjects. The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept studies.
Healthy male and female subjects age 18 to 45 years of age included.
Participant must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18-32 kg/m2 inclusive.
The participant has normal results or abnormalities without clinical significance as judged by the investigator for vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), 12-lead electrocardiogram (ECG).
Fully understand the trial content, procedures, and possible adverse reactions; voluntarily participate and sign the informed consent form (ICF).
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.
Parallel
LG-0317
DrugSubjects are planned to be dosed in oral tablet, with single and multiple ascending doses
Placebo
DrugSubjects are planned to be dosed in oral tablet, with single and multiple ascending doses
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with clinically significant laboratory assessment abnormalities
Number of participants with clinically significant Vital sign abnormalities
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
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