Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
Public ClinicalTrials.gov record NCT05321602. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05321602
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 89 participants
Conditions and interventions
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
- LY03010 156 mg treatment group, deltoid Drug
- LY03010 156 mg treatment group, gluteal Drug
- LY03010 351 mg treatment group, deltoid Drug
- LY03010 351 mg treatment group, gluteal Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 8, 2021 (Actual)
- Primary completion
- Sep 23, 2022 (Actual)
- Completion
- Oct 23, 2022 (Actual)
- Last update posted
- Mar 19, 2024
2021 – 2022
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| CNS Research | Garden Grove | California | 92845 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Collaborative Neuroscience Network, LLC | Torrance | California | 90502 | — |
| Innovative Clinical Research | Miami Lakes | Florida | 33016 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| CBH Health | Gaithersburg | Maryland | 20877 | — |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05321602, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2024 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05321602 live on ClinicalTrials.gov.