A Randomized, Single and Multiple Ascending Doses, Food-effect Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 Tablets in Healthy Chinese Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with clinically significant Vital sign abnormalities
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
- •Able to communicate well with the study personnel, and understand and comply with the relevant requirements of the trial.
排除标准
- •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.
研究组 & 干预措施
LG-0317
干预措施: LG-0317 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with clinically significant Vital sign abnormalities
时间窗: Day 1 to day 18
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
时间窗: Day 1 to day 18
Number of participants with clinically significant physical examination abnormalities
时间窗: Day 1 to day 18
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 to day 18
Number of participants with clinically significant laboratory assessment abnormalities
时间窗: Day 1 to day 18
次要结局
未报告次要终点