AzTrials
AzTrials

Major Depressive DisorderPhase 1NCT06476509

A Study to Assess Serotonin Transporter Occupancy of Healthy Adults Using 11C-DASB PET

A Phase 1 study testing LV232 40mg, Escitalopram 20 mg and LV232 60mg in people with Major Depressive Disorder, run by Vigonvita Life Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study was a non-randomized, open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography (PET) Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Major Depressive Disorder
What is being tested?
LV232 40mg, Escitalopram 20 mg and LV232 60mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
30 May 2024to 23 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial;
  • Male and female, aged 18 to 45 years at the time of signing the informed consent form;
  • Body weight, male≥ 50.0 kg ,female≥ 45.0 kg ,and body mass index (BMI) 19.0 ~ 26.0 kg/m2 (including the boundary value) at screening;
  • Able to maintain good communication with the investigator and comply with the lifestyle restrictions specified in the protocol and various requirements of the clinical trial (scheduled visits, laboratory tests and other trial procedures);
  • Subjects and their partners must use effective non-pharmacological contraception (e.g., abstinence and condom with intravaginal spermicide) throughout the study and for 6 months after the end of the study, and must not donate sperm.

Who cannot join

  • Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (previous allergy to two or more foods or drugs);
  • The subject with skin diseases or has a history of skin allergies;
  • The subject has a current or past medical history judged by the investigator that may affect the clinical trial or dysfunction, including but not limited to a past or present central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. that require medical intervention or other diseases that are not suitable for clinical trials (such as a history of mental illness);
  • Individuals with a history of epileptic seizures, or those with any (acute or chronic) history of mental illness and family history of mental illness, or those with a history of neurodegenerative diseases and family history of neurodegenerative diseases, such as Alzheimer's disease;
  • Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, etc.;
  • Abnormal vital signs (resting pulse rate<55 beats/minute or>100 beats/minute; Systolic blood pressure<90 mmHg or ≥ 140 mmHg; Diastolic blood pressure<60 mmHg or ≥ 90 mmHg), laboratory tests (blood routine , blood biochemistry, urine routine, thyroid Function), 12 electrocardiogram (ECG, male QTcF>450 ms，female QTcF>460 ms), MRI (magnetic resonance imaging) examination indicators, judged by the investigator as abnormal and clinically significant;
Show all 20Show fewer
  • Use of any prescription medication within 28 days prior to dosing; Use of any over-the-counter medications, including health products, within 7 days prior to dosing; Receipt of any contrast agent or radiopharmaceutical within 7 days prior to, or application of contrast agent within 24 hours after, administration of the trial drug;
  • Contraindications to PET or MRI (magnetic resonance imaging) (including claustrophobia, alcohol allergy, cardiac pacemaker and nerve stimulator in the body, metal foreign body in the body or tracer component allergy, etc.);
  • Any positive result of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab) and Toluidine red unheated serum test (Trust);
  • Smoking habit (an average daily smoking of ≥ 5 cigarettes per day within 3 months before administration), drinking habit (an average weekly drinking of more than 14 standard units within 3 months before administration, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine). Subjects who cannot quit smoking or drinking in clinical trials.
  • Individuals who have a history of drug dependence (including drug use) within one year prior to administration, or who have tested positive for urinary drug abuse screening (benzodiazepines, cocaine, methamphetamine, amphetamine, methadone, tetrahydrocannabinol acid, barbiturates, morphine, phencyclidine, tricyclic antidepressants);
  • Those who have special requirements for food and cannot abide by the unified diet or have dysphagia;
  • Consumption of xanthine-rich foods or beverages (e.g., tea, coffee, cola, or chocolate) or foods or beverages containing grapefruit and/or pomelo within 3 days before dosing;
  • Significant occupational exposure to ionizing radiation (e.g., more than 50 millivolts per year) or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes within the past year;
  • Blood donation or blood loss ≥ 400 mL within 3 months before administration, or blood donation or blood loss ≥ 200 mL within one month;
  • Those who have participated in other clinical trials within 3 months before administration (including drug and medical device clinical trials, the time is based on the last visit, except for those who have failed screening in other clinical trials and have not received any treatment);
  • Pregnant, lactating women or male subjects whose spouses have a parenting plan within 3 months;
  • Individuals who cannot tolerate intravenous administration ;
  • Personnel directly related to this clinical trial;
  • Patients with poor compliance or other problems who are not suitable for participating in this trial in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Mental Health Center Ethics Committee

    Shanghai

Other trials in China

About this study

Official title: A Non-Randomized, Open-Label, Exploratory Mechanistic Validation (PoM) Clinical Trial of LV232 Capsule Assessing Serotonin Transporter Occupancy in the Healthy Adult Brain Using 11C-DASB Positron Emission Tomography (PET)

This study was a non-randomized, open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography (PET)

Read the detailed description

This trial adopts a single-center, non-randomized, open-label design, with a planned enrollment of 16 healthy subjects. The LV232 capsule groups include 6 subjects in the 40 mg dose group, 4 subjects in the 60 mg dose group, and 4 subjects in the 20 mg dose group. Additionally, there are 2 subjects in the escitalopram oxalate tablet (positive control drug) group. Based on the results of the LV232 capsule study, the investigator and sponsor will jointly decide whether to proceed with the positive control group, using escitalopram oxalate tablets at a dose of 20 mg as the positive control drug.

Being tested
LV232 40mg, Escitalopram 20 mg, LV232 60mg, LV232 20mg
Medical subject headings
Depressive Disorder, Major

What participants receive

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

  • LV232 40mgDrug

    Also called LV232

    oral

  • Escitalopram 20 mgDrug

    Also called Escitalopram

    oral

  • LV232 60mgDrug

    Also called LV232

    oral

  • LV232 20mgDrug

    Also called LV232

    oral

Study groups in NCT06476509
Study groupRoleWhat they receive
LV232ExperimentalA single oral dose of 40mg LV232 (5 mg/capsule, 8 capsules each time) ，administrated in fasting state, with 240 mL water to take A single oral dose of 60mg LV232 (5 mg/capsule, 12 capsules each time) ，administrated in fasting state, with 240 mL water to take A single oral dose of 20mg LV232 (5 mg/capsule, 4 capsules each time) ，administrated in fasting state, with 240 mL water to take
Receives: Drug: LV232 40mg; Drug: LV232 60mg; Drug: LV232 20mg
EscitalopramActive comparatorA single oral dose of 20mg Escitalopram (10 mg/tablet, 2 tablets each time) , administrated with 240 mL water
Receives: Drug: Escitalopram 20 mg

What is being measured

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

  1. Serotonin Transporters occupancy

    Percentage of Serotonin Transporters Occupancy in Human Brain after oral LV232 capsule

    Measured: baseline and 3 hours after administration on Day 1

Secondary outcomes (1)

  1. Incidence of treatment-emergent adverse events (TEAEs).

    Incidence of treatment-emergent adverse events (TEAEs)

    Measured: Up to Day 7

Timeline

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

  1. First posted26 Jun 2024
  2. Study start30 May 2024
  3. Primary completion19 Jan 2025
  4. Study completion23 May 2025

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
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476509
Sponsor's protocol ID
LV232-03
Status last verified
Feb 2025
First submitted
18 Jun 2024
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LV232 40mg, Escitalopram 20 mg and LV232 60mg in people with Major Depressive Disorder, run by Vigonvita Life Sciences at 1 site in China.

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: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serotonin Transporters occupancy (time frame: baseline and 3 hours after administration on 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 NCT06476509.

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 10 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in