LY03020 for Schizophrenia and Alzheimer's Disease Psychosis
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Recruiting
Phase 1Interventional Study
SchizophreniaAlzheimer's Disease Psychosis
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Luye Pharma Group Ltd. · Industry
Who this trial is looking for
This trial is looking for healthy adults or those with stable schizophrenia. Participants will take the study drug or a placebo to help researchers understand its safety and effects.
Are You a Good Fit for This Trial?
Must not be takingMonoamine oxidase inhibitors
Rules you outCongenital long QT syndromeSevere cardiovascular diseaseAllergic diseases
You may be able to join if
I am between 18 and 60 years old.
I weigh at least 50 kg if male or 45 kg if female.
I have a body mass index (BMI) within specific limits.
I have signed the consent form voluntarily.
I have a diagnosis of schizophrenia and my condition is stable.
I have a PANSS total score of 80 or less.
You may not be able to join if
I have a significant medical condition or chronic disease.
I have taken prescription drugs in the past 28 days.
I have a history of keratopathy or certain eye diseases.
I have had low blood pressure or fainting issues.
I have had surgery in the past 3 months or am planning surgery.
I have a history of suicide attempts or suicidal thoughts in the past 6 months.
I have uncontrolled cardiovascular disease.
I have used certain medications or supplements shortly before the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and/or subjects with stable schizophrenia.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
Healthy Subjects
* Subjects sign informed consent voluntarily.
* Male or female aged 18 to 45 years.
* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2 Subjects with Stable Schizophrenia
* Subjects themselves and / o…
Inclusion Criteria:
Healthy Subjects
* Subjects sign informed consent voluntarily.
* Male or female aged 18 to 45 years.
* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2 Subjects with Stable Schizophrenia
* Subjects themselves and / or their guardians sign informed consent voluntarily.
* Male or female aged 18 to 60 years.
* Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 32.0 kg/m2.
* Subject must meet the DSM-V criteria for a primary diagnosis of schizophrenia. Subject must have a PANSS total score ≤ 80 and CGI-S score ≤ 4 at screening. The condition is stable from 1 month before signing informed consent to baseline.
Exclusion Criteria:
Healthy Subjects
* Subjects have any clinically significant medical condition or chronic disease.
* Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
* Subjects with a history of orthostatic hypotension or syncope.
* Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
* Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
* Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
* Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation
* Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody. Subjects with Stable Schizophrenia
* According to the DSM-5, there were other mental disorders except schizophrenia within 6 months before screening period.
* Assessed by the investigator as having treatment-resistant schizophrenia; past or current diagnosis of neuroleptic malignant syndrome (NMS); anticipated need for antipsychotic regimen modifications during the study period;
* History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) or suicidal ideation within the past 6 months, defined as affirmative responses ("yes") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening/baseline;
* Subjects have used monoamine oxidase inhibitors (MAOI) within 28 days or any dietary supplements/traditional Chinese herbal products within 7 days prior to first dosing.
* Glycated hemoglobin (HbA1c) ≥7% at screening/baseline.
* Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate \<50 beats per minute (bpm) at screening/baseline; or QTc \>450 ms (male) / QTc \>460 ms (female) based on Fridericia's formula-corrected measurements at screening/baseline.
* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
* Subjects with a history of orthostatic hypotension or syncope.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.