NCT07522970 A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 in Healthy Participants
| NCT ID | NCT07522970 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | LinGang Laboratory |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2026-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-04-20 with a primary completion date of 2026-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07522970 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07522970 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07522970 currently recruiting?
Yes, NCT07522970 is actively recruiting participants. Contact the research team at feng.wang@lglab.ac.cn for enrollment information.
Where is the NCT07522970 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07522970 clinical trial?
NCT07522970 is sponsored by LinGang Laboratory. The trial plans to enroll 100 participants.