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

NCT06556966 | Completed Phase 1

• 1 other identifier: LY03020/CT-CHN-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Alzheimer's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events (AEs)

  Percentage of adverse events

  up to144 hours

Secondary Outcomes (7)

• Maximum observed concentration (Cmax) of LPM787000048 in plasma

  up to144 hours

• Time to maximum observed concentration (Tmax) of LPM787000048 in plasma

  up to144 hours

• Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma

  up to144 hours

• 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

• Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma

  up to144 hours

Other Outcomes (1)

• Quantitatively determine the concentration of LPM787000048 and major metabolites (if applicable) in urine and calculate the cumulative excretion ratio in urine.

  up to144 hours

Study Arms (2)

LY03020

EXPERIMENTAL

Subjects will take single-dose LY03020 on Day 1

Drug: LY03020

Placebo

SHAM COMPARATOR

Subjects will take single-dose Placebo on Day 1

Drug: Placebo

Interventions

LY03020 DRUG

LY03020 for one single dose

Also known as: LPM787000048 Maleate sustained-release tablet

LY03020

Placebo DRUG

Placebo for one single dose

Also known as: Placebo of LPM787000048 Maleate sustained-release tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Beijing AnDing Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Gang Wang

  Beijing AnDing Hospital Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: August 19, 2024
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)