A Phase 1 interventional study of LG-0317 and Placebo in Healthy Volunteers, sponsored by LinGang Laboratory. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by LinGang Laboratory · Phase 1, Interventional, and Treatment
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.
LinGang Laboratory is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: LG-0317
Drug: Placebo
Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
Subjects 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)
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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