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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: Completed Phase 1 study, sponsored by Luye Pharma Group.
NCT05321602 is a Phase 1 study that has completed, run by Luye Pharma Group. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To characterize the PK profile of paliperidone in LY03010 from time zero through the last quantifiable concentration The PK profile of LY03010 will be evaluated by the analysis of the area under the concentration-time curve from time zero through the time of the last quantifiable concentration (AUC0-t) and extrapolated through infinity (AUC0-inf).
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 |
What the finished NCT05321602 record still lists
NCT05321602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 4 interventions - of which LY03010 156 mg treatment group, deltoid is the first listed.
NCT05321602 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05321602's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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