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NCT05321602 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
A Phase 1 study, sponsored by Luye Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT05321602 is a Phase 1 study that has completed, run by Luye Pharma Group. The registered enrollment target is 89 participants.
The verdict
NCT05321602, a Phase 1 study, has completed, sponsored by Luye Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
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.
Interventions
- DRUG 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2022-10-23 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05321602
The ClinicalTrials.gov registry entry for NCT05321602 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Luye Pharma Group, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which LY03010 156 mg treatment group, deltoid is the first listed.
NCT05321602 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05321602 about?
NCT05321602 is a clinical study titled "Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder". 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.
What is the current status of trial NCT05321602?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2021-09-08. Estimated completion is 2022-10-23.
What interventions are being tested in trial NCT05321602?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT05321602?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
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