Not Yet RecruitingPhase 1

An Open-Label PET/CT Imaging Study to Evaluate Brain Serotonin Transporter (SERT) Occupancy Following Single-Dose Administration of LG-0317 Tablets in Healthy Participants

12 participantsStarted 2026-07-24

Plain-language summary

The purpose of the study is to evaluate brain serotonin transporter (SERT) receptor occupancy (RO) following single oral doses of LG-0317 tablets in healthy male participants; and to explore the pharmacokinetic/pharmacodynamic (PK/PD) relationship between LG-0317 plasma concentrations and SERT occupancy..

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Healthy male 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 19-28 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: * 1\) Allergic constitution, history of allergic diseases, or known allergy to the investigational product, its excipients, or related products. 2\) History of current or prior neurological disorders, including but not limited to: history of head trauma or concussion; history of stroke or known cerebrovascular diseases (e.g., intracranial aneurysm, arteriovenous malformation); or other known structural abnormalities of the brain. 3\) History of serious unstable diseases or related medical history affecting the hepatic, renal, gastrointestinal, endocrine, cardiovascular (including known aneurysmal vascular lesions), metabolic, hematological, respiratory, or autoimmune systems. 4\…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Receptor Occupancy: SERT occupancy in brain ROIs post single-dose of LG-0317 as measured by PET/CT.

Timeframe: Day 1

Trial details

NCT IDNCT07708428

SponsorLinGang Laboratory

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Feng Wang

021-64220292 feng.wang@lglab.ac.cn

View on ClinicalTrials.gov More Healthy Volunteers (HV) trials