NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 8, 2021

Primary Completion Date

September 23, 2022

Study Completion Date

October 23, 2022

Conditions

SchizophreniaPsychotic DisordersMood DisordersSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersAntipsychotic AgentsTranquilizing AgentsCentral Nervous System DepressionPhysiological Effects of DrugsPsychotropic DrugsNeurotransmitter AgentsMolecular 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.

Trial Locations (9)

20877

CBH Health, Gaithersburg

30331

Atlanta Center for Medical Research, Atlanta

33016

Innovative Clinical Research, Miami Lakes

60640

Uptown Research Institute, Chicago

72211

Woodland International Research Group, Little Rock

75115

InSite Clinical Research, LLC, DeSoto

90502

Collaborative Neuroscience Network, LLC, Torrance

92845

CNS Research, Garden Grove

92868

NRC Research Institute, Orange

All Listed Sponsors

lead

Luye Pharma Group Ltd.

INDUSTRY