A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-
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.
| Condition(s) | Healthy Volunteers |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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. Exclusi |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | LinGang Laboratory |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2026-04-20 |
| NCT ID | NCT07522970 |
| Official listing | https://clinicaltrials.gov/study/NCT07522970 |