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Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder

NCT05321602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2024-03-19

No results posted yet for this study

Summary

This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.

Conditions

  • Schizophrenia
  • Psychotic Disorders
  • Mood Disorders
  • Schizophrenia Spectrum and Other Psychotic Disorders
  • Mental Disorders
  • Antipsychotic Agents
  • Tranquilizing Agents
  • Central Nervous System Depression
  • Physiological Effects of Drugs
  • Psychotropic Drugs
  • Neurotransmitter Agents
  • Molecular Mechanisms of Pharmacological Action

Interventions

DRUG

LY03010 156 mg treatment group, deltoid

LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.

DRUG

LY03010 156 mg treatment group, gluteal

LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.

DRUG

LY03010 351 mg treatment group, deltoid

LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.

DRUG

LY03010 351 mg treatment group, gluteal

LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Rui Li, MD · Luye Pharma US Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2022-09-23
Completion
2022-10-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321602 on ClinicalTrials.gov