A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LG-0317, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug LG-0317
Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses - Drug Placebo
Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
Primary outcome measures
- 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 criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Xuhui Central Hospital — Shanghai
Identifiers
NCT: NCT07522970 · LG-0317-01