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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LG-0317 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LG-0317 | Drug | Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 to day 18 | |
| Number of participants with clinically significant laboratory assessment abnormalities | Day 1 to day 18 | |
| Number of participants with clinically significant Vital sign abnormalities | Day 1 to day 18 | |
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities | Day 1 to day 18 | |
| Number of participants with clinically significant physical examination abnormalities | Day 1 to day 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Translational Clinical Group officer | Contact | 021-64220292 | feng.wang@lglab.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Recruiting | Shanghai | Shanghai Municipality | 200237 | China |
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Study drug: LG-0317 and placebo. In the single ascending dose part, subjects will be randomized and dosed in different cohorts with a single dose. In the multiple ascending dose part, subjects will be randomized and dosed in different cohorts with multiple doses.
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| Placebo | Drug | Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses |
|