A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLuye Pharma Group Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LY03020
Drugadministered orally
Placebo
Drugadministered orally
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: LY03020Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Time frame
up to Day 11Secondary outcomes
1
Number of participants with clinical laboratory assessment abnormalities.
Time frame
up to Day 112
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 11 of subjects with stable schizophrenia
The total score range is 30 to 210.A higher score is associated with greater illness severity.
Time frame
up to Day 113
Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) at Day 11 of subjects with stable schizophrenia
This scale is divided into three parts, which are evaluated suicidal ideation(5 items \[yes/no\])，intensity of ideation (5 items on 5-point scales; scores range from 0 to 25 with higher scores indicating more intense suicidal ideation),and suicide behavior(actual attempt,interrupted attempt,aborted attempt, preparatory acts or behavior).
Time frame
up to Day 114
Change from Baseline in Barnes Akathisia Rating Scale (BARS) at Day4 and Day 11 of subjects with stable schizophrenia
The total score range is 0 to 14.A higher score is associated with greater illness severity.
Time frame
up to Day 11Sponsors and contacts
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Source ClinicalTrials.gov