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Recruiting Phase 1

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 in Healthy Participants

NCT07522970 · tracked via the Priya Life Science China tracker
Sponsor
LinGang Laboratory
Phase
Phase 1
Started
2026-04-20
Last updated
2026-06-25

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

LG-0317Placebo

LG-0317: Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses

Placebo: Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Shanghai Xuhui Central Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07522970 on ClinicalTrials.gov ↗ ← All trials in China