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Healthy Volunteers (HV)Phase 1NCT07708428

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

A Phase 1 study testing Cohort 1: LG-0317 20 mg, Cohort 1: LG-0317 40 mg and Cohort 1: LG-0317 80 mg in people with Healthy Volunteers (HV), run by LinGang Laboratory.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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.. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers (HV)
What is being tested?
Cohort 1: LG-0317 20 mg, Cohort 1: LG-0317 40 mg and Cohort 1: LG-0317 80 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
24 Jul 2026to 2 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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) History of psychiatric disorders, substance abuse, or drug dependence. 5) Presence of epileptiform abnormalities (EAs) on screening electroencephalogram (EEG). (Screening EEG will include hyperventilation and intermittent photic stimulation as activation procedures.) 6) Personal history of epilepsy or family history of epilepsy in first-degree relatives (i.e., parents, siblings, or children).
  • 7) Suicidal risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); specifically, if the participant answers "yes" to Question 4 or 5 of the Suicidal Ideation section of the C-SSRS during screening and the most recent intent or plan occurred within the past 6 months; or answers "yes" to any question in the Suicidal Behavior section occurring within the past 2 years; or deemed at suicidal risk based on the investigator's clinical judgment.
  • 8) Any relevant history of illness, surgery, or trauma within 3 months prior to the first dose that could affect safety or pharmacokinetics, or planned surgery during the study period.
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  • 9) Inability to swallow tablets. 10) Difficult venous access, intolerance to venipuncture/indwelling catheters, or history of vasovagal syncope (fainting) related to needles/blood (needle-phobia or hemophobia).
  • 11) Excessive consumption (>8 cups/day; 1 cup = 250 mL) of tea, coffee, or caffeinated beverages within 3 months prior to screening; or consumption of chocolate, caffeine-containing products, alcohol, grapefruit/grapefruit juice, or xanthine-rich foods/beverages within 48 hours prior to the first dose.
  • 12) Alcohol consumption exceeding 21 standard units per week within 3 months prior to screening (1 standard unit contains 14 g of alcohol, e.g., 360 mL beer, 45 mL liquor at 40% alcohol, or 150 mL wine); or positive result on breath alcohol testing.
  • 13) Smoking history ≥5 cigarettes per day within 3 months prior to screening. 14) Use of any prescription drugs, over-the-counter medications, herbal remedies, or dietary supplements within 14 days prior to the first dose.
  • 15) Participation in another clinical trial involving investigational product within 3 months prior to the first dose.
  • 16) Blood donation or significant blood loss (>400 mL), or receipt of blood transfusion within 3 months prior to the first dose.
  • 17) Participation in a clinical study involving radiation exposure within the past 12 months, or receipt of significant diagnostic/therapeutic radiation exposure for medical reasons within the past 12 months, leading to an estimated cumulative annual radiation dose exceeding safety limits (e.g., ≥10 mSv) based on ICRP recommendations.
  • 18) Any contraindication to PET/CT or MRI scanning, including but not limited to: presence of implanted metallic objects (e.g., cardiac pacemaker, metal prosthesis, implanted neurostimulator); claustrophobia; or body habitus/weight unsuitable for the PET/CT or MRI scanner bore. Note: Contraindications identified during any prior MRI scan or the baseline MRI conducted prior to the screening PET/CT scan also apply.
  • 19) Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (syphilis).
  • 20) Use of illicit drugs within 3 months prior to screening or positive urine drug screen (including morphine, methamphetamine, methadone, phencyclidine [PCP], tetrahydrocannabinol carboxylic acid [THC-COOH], amphetamine, cocaine, barbiturates, benzodiazepines, ketamine, tricyclic antidepressants).
  • 21) Plan to conceive, donate sperm, or unwillingness to use effective contraception during the study and for 3 months after the last dose.
  • 22) Known photosensitive disorder or history of abnormal sensitivity to sunlight.
  • 23) Affiliation with the study site staff, employment by the sponsor, or being an immediate family member of such personnel.
  • 24) Any other condition that, in the investigator's opinion, makes the participant unsuitable for inclusion in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Feng Wang contact

021-64220292

feng.wang@lglab.ac.cn

About this study

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..

Read the detailed description

This is a single-center, open-label, adaptive-design, exploratory Phase I PET/CT imaging study involving single-dose administration in healthy male participants. The study aims to evaluate brain serotonin transporter (SERT) occupancy following administration of LG-0317 using positron emission tomography (PET) and to investigate the pharmacokinetic/pharmacodynamic (PK/PD) relationship between plasma concentrations of LG-0317 and receptor occupancy.

The study employs a parallel-group, adaptive design without blinding, randomization, or placebo control. A total of 12 participants are anticipated to be enrolled and allocated into three dose cohorts.

Being tested
Cohort 1: LG-0317 20 mg, Cohort 1: LG-0317 40 mg, Cohort 1: LG-0317 80 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort 1: LG-0317 20 mgDrug

    Subjects will receive single dose of LG-0317 tablets.

  • Cohort 1: LG-0317 40 mgDrug

    Subjects will receive single dose of LG-0317 tablets.

  • Cohort 1: LG-0317 80 mgDrug

    Subjects will receive single dose of LG-0317 tablets.

Study groups in NCT07708428
Study groupRoleWhat they receive
Cohort 1: LG-0317 20 mgExperimentalSubjects will receive single dose of LG-0317 tablets.
Receives: Drug: Cohort 1: LG-0317 20 mg
Cohort 2: LG-0317 40 mgExperimentalSubjects will receive single dose of LG-0317 tablets.
Receives: Drug: Cohort 1: LG-0317 40 mg
Cohort 3: LG-0317 80 mgExperimentalSubjects will receive single dose of LG-0317 80mg tablets.
Receives: Drug: Cohort 1: LG-0317 80 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1

Secondary outcomes (6)

  1. Pharmacokinetics: maximum plasma concentration (Cmax)

    Measured: Day 3

  2. Pharmacokinetics: time to reach Cmax(Tmax)

    Measured: Day 3

  3. Pharmacokinetics: area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)

    Measured: Day 3

  4. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 10

  5. Number of participants with clinically significant laboratory assessment abnormalities

    Measured: Day 10

  6. Number of participants with clinically significant Vital sign abnormalities

    Measured: Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start24 Jul 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Subjects will be assigned in parallel to different cohorts and receive single dose of LG-0317, and undergo one post dose PET/CT scan
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07708428
Sponsor's protocol ID
LG-0317-RO-01
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cohort 1: LG-0317 20 mg, Cohort 1: LG-0317 40 mg and Cohort 1: LG-0317 80 mg in people with Healthy Volunteers (HV), run by LinGang Laboratory.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Feng Wang (021-64220292, feng.wang@lglab.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receptor Occupancy: SERT occupancy in brain ROIs post single-dose of LG-0317 as measured by PET/CT. (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07708428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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