A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Schizophrenia; Alzheimer's Disease Psychosis
• Interventions: Drug: LY03020; Drug: Placebo

• Registration Number: NCT06556966
• Lead Sponsor: Luye Pharma Group Ltd.

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.

Detailed Description

The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 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 male or female greater than or equal to 18.5 but less than 26.0 kg/m2 of body mass index (BMI).

Exclusion Criteria

• Subjects have any clinically significant medical condition or chronic disease.
• Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure,or angle-closure glaucoma.Subjects have a abnormal and clinically significant test for ophthalmic examination during screening.
• 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 used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
• 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 serum reaction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY03020	LY03020	Subjects will take single-dose LY03020 on Day 1
Placebo	Placebo	Subjects will take single-dose Placebo on Day 1

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs)	up to144 hours	Percentage of adverse events

Secondary Outcome Measures

Name	Time	Method
Time to maximum observed concentration (Tmax) of LPM787000048 in plasma	up to144 hours	Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Maximum observed concentration (Cmax) of LPM787000048 in plasma	up to144 hours	Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma	up to144 hours	Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma	up to144 hours	Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma	up to144 hours	Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Apparent volume of distribution（Vz/F） of LPM787000048 in plasma	up to144 hours	Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Apparent total body clearance (CL/F) of LPM787000048 from plasma	up to144 hours	Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.