ClinicalTrials.gg
Enrolling by invitationNCT07371065Updated Jan 27, 2026

To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects

A Phase 1 interventional study of LY03021 and placebo in Major Depressive Disorder, sponsored by Luye Pharma Group Ltd.. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's planned enrollment of 98 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Luye Pharma Group Ltd. is the lead sponsor of 74 studies on the registry; 15 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Those who voluntarily participate in and sign the form after understanding the purpose, content, process and possible risks of the trial;
  2. Healthy male/female volunteers between 18 and 45 years of age, inclusive, at the time of signing the informed consent form;
  3. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and (BMI) 18.5 kg/m2\~ 28.0 kg/m2 (including the boundary value) at screening;
  4. Be able to communicate well 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).

Exclusion criteria

Exclusion Criteria:

  1. Known to have a history of allergy to any component of the product or similar drugs, or allergic constitution (previous allergy to two or more foods or drugs);
  2. The subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to a past or present respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and any other disease or chronic disease; or any other disease that may interfere with the test results;
  3. Any surgical conditions or conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a risk to the subjects participating in the trial, including a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, etc.;
  4. Subjects with current or past mental disorders and brain dysfunction, or at risk of suicide according to Columbia-Suicide Severity Rating Scale (C-SSRS), or having a suicide risk at the discretion of the Investigator, , or with a history of self-mutilation;
  5. History of substance abuse or positive result in urine drug screening within 1 year prior to dosing;
  6. History of alcohol abuse (defined as more than 14 standard units of alcohol per week, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) or positive breath test results within 1 year before dosing;
  7. Subjects who have a history of surgery within 3 months before dose administration, or have not recovered from surgery, or have an anticipated surgical planning during the trial;
  8. Those who have participated in other clinical trials within 3 months before dose administration (including drug and medical device clinical trials, the time is based upon the last visit);
  9. Blood donation or blood loss ≥ 400 mL within 3 months before dose administration, or blood donation or blood loss ≥ 200 mL within one month, or having a history of using blood products;
  10. Pregnant and lactating women; and those who refuse to take effective measures (such as abstinence, intrauterine device or condom with intravaginal spermicide, etc.) during the study period and within 28 days after the end of the study, or have the plan to donate sperm or eggs;
  11. Abnormalities in vital signs, laboratory tests and 12-lead (ECG) , and clinically significant as judged by the Investigator, for example:

    > 450 ms for males and > 460 ms for females, Friericia's correction; Resting pulse rate \< 55 beats/min or > 100 beats/min; systolic blood pressure \< 90 mmHg or ≥ 140 mmHg; diastolic blood pressure \< 60 mmHg or ≥ 90 mmHg;

  12. Use of the following medications or treatments prior to dosing:

    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;

  13. surface antigen (HBsAg), antibody (HCV-Ab), antibody (HIV-Ab), syphilis serum reaction (Trust) non-negative;
  14. The average daily smoking of ≥ 5 cigarettes within 3 months before dose administration;
  15. Those who have special requirements for food and cannot abide by the unified diet or have dysphagia;
  16. Consumption of food or beverages containing grapefruit and/or pomelo within 7 days prior to dosing;
  17. Consumption of xanthine-rich foods or beverages (such as tea, coffee, cola or chocolate) within 3 days before dose administration;
  18. Poor compliance or any condition that is considered as unsuitable for the study participation by the Investigator.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
98 participants (estimated)

Study arms

  • Experimental
    LY03021 group

    Orally only once

    Drug: LY03021

  • Sham comparator
    Placebo

    Orally only once

    Drug: placebo

Interventions

  • DrugLY03021

    Orally only once

  • Drugplacebo

    Orally only once

06

What researchers measure

Primary outcomes

  1. Adverse Event

    Time frame: Day 12

Secondary outcomes

  1. PK parameters: Cmax

    Time frame: Day 12

  2. PK parameters: Tmax

    Time frame: Day 12

07

Study locations

1 site
  • No. 604 Lingling Road, Shanghai
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07371065
Responsible party
Sponsor
First posted
Jan 27, 2026
Start date
Oct 28, 2025
Primary completion
Apr 30, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Jan 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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