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Tests treatment safety and results for Schizophrenia
Official title A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
ClinicalTrials.gov ID: NCT07230652
What this study is testing
What is LY03020?
LY03020 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Healthy people
- people 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 people with Stable Schizophrenia
- people themselves and / or their guardians sign informed consent voluntarily.
You likely can't join if
- Healthy people
- people have any clinically significant medical condition or chronic disease.
- people have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
- people experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. people have any abnormal and...
- people with a history of orthostatic hypotension or syncope.
- people with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
See the full eligibility criteria
- Healthy people
- people 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 people with Stable Schizophrenia
- people 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...
- Healthy people
- people have any clinically significant medical condition or chronic disease.
- people have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
- people experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. people have any abnormal and clinically significant test for ophthalmic examination during...
- people with a history of orthostatic hypotension or syncope.
- people with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
- people had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
- people have any clinically significant abnormal vital signs, laboratory values, and ECGs.
- people have a history of allergic diseases, or allergic to any substance contained in the formulation
- people have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody. people 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...
- 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...
- people 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...
- people experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. people have any abnormal and clinically significant test for ophthalmic examination during...
- people with a history of orthostatic hypotension or syncope.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.