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.
This study consists of three parts: single ascending dose, food effect , and multiple ascending dose. The single ascending dose part consists of a screening period (4 weeks), a dosing observation period and a follow-up period. Participants in different dose groups will be enrolled sequentially according to the dose escalation principle. In the food effect part, eligible participants will be randomly assigned to Sequence 1 or Sequence 2 prior to dosing in the first period. Participants will receive a single oral dose of LG-0317 tablet either under fasting conditions or after a high-fat, high-calorie meal, depending on their assigned sequence. The multiple ascending dose part will include 3-4 dose groups, and the dose levels will be determined based on the safety, tolerability, and available PK and PD data obtained from the single ascending dose part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to day 18
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Day 1 to day 18
Number of participants with clinically significant Vital sign abnormalities
Time frame: Day 1 to day 18
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Day 1 to day 18
Number of participants with clinically significant physical examination abnormalities
Time frame: Day 1 to day 18
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