Major Depressive DisorderPhase 1NCT07371065
To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects
A Phase 1 study testing LY03021 in people with Major Depressive Disorder, run by Luye Pharma Group Ltd. at 1 site in China.
Trial 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. 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?
- LY03021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to 30 Apr 2026
- 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
- 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;
- Healthy male/female volunteers between 18 and 45 years of age, inclusive, at the time of signing the informed consent form;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 kg/m2~ 28.0 kg/m2 (including the boundary value) at screening;
- 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).
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 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 clinically significant disease or chronic disease; or any other disease that may interfere with the test results;
- 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.;
- 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;
- History of substance abuse or positive result in urine drug screening within 1 year prior to dosing;
- 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;
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- 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;
- 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);
- 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;
- Pregnant and lactating women; and those who refuse to take effective contraception 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;
- Abnormalities in vital signs, laboratory tests and 12-lead electrocardiogram (ECG) , and clinically significant as judged by the Investigator, for example:
- QTc > 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;
- 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;
- Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), syphilis serum reaction (Trust) non-negative;
- The average daily smoking of ≥ 5 cigarettes within 3 months before dose administration;
- Those who have special requirements for food and cannot abide by the unified diet or have dysphagia;
- Consumption of food or beverages containing grapefruit and/or pomelo within 7 days prior to dosing;
- Consumption of xanthine-rich foods or beverages (such as tea, coffee, cola or chocolate) within 3 days before dose administration;
- Poor compliance or any condition that is considered as unsuitable for the study participation by the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, be Consistency and Food Effects of LY03021 Tablets in Healthy Subjects
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.
- Conditions
- Major Depressive Disorder
- Being tested
- LY03021, placebo
- 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.
LY03021Drug
Orally only once
placeboDrug
Orally only once
| Study group | Role | What they receive |
|---|---|---|
| LY03021 group | Experimental | Orally only once Receives: Drug: LY03021 |
| Placebo | Sham comparator | Orally only once Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Measured: Day 12
Secondary outcomes (2)
PK parameters: Cmax
Measured: Day 12
PK parameters: Tmax
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start28 Oct 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371065
- Sponsor's protocol ID
- LY03021/CT-CHN-101
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, be Consistency and Food Effects of LY03021 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07371065
- Acronym / sponsor ID
- LY03021/CT-CHN-101
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY03021 group | Experimental | Drug: LY03021Orally only once |
| Placebo | Sham comparator | Drug: placeboOrally only once |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial;
- Healthy male/female volunteers between 18 and 45 years of age, inclusive, at the time of signing the informed consent form;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 kg/m2~ 28.0 kg/m2 (including the boundary value) at screening;
- 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).
Key exclusion criteria (20 listed)
- 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 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 clinically significant disease or chronic disease; or any other disease that may interfere with the test results;
- 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.;
- 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;
- History of substance abuse or positive result in urine drug screening within 1 year prior to dosing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY03021Orally only once | Drug | LY03021 group |
| placeboOrally only once | Drug | Placebo |
Primary outcome
Adverse Event
Time frame: Day 12
2 secondary outcomes
PK parameters: Cmax
Time frame: Day 12
PK parameters: Tmax
Time frame: Day 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY03021 in people with Major Depressive Disorder, run by Luye Pharma Group Ltd. 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 4 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: enrolling by invitation, as of the sponsor's last update on 27 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
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?
Adverse Event (time frame: Day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.