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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07522970

Run by

LinGang Laboratory

People needed

100

Starts

2026-04-20

Expected to finish

2026-09-10

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Xuhui Central Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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