Schizophrenia PatientsPhase 1NCT04572685
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
A Phase 1 study testing Paliperidone Palmitate in people with Schizophrenia Patients, run by Luye Pharma Group Ltd. at 1 site in United States.
Trial summary
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Patients
- What is being tested?
- Paliperidone Palmitate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 20 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 to ≤65 years of age who meets diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for at least 1 year before screening
- Have been on a stable dose of oral antipsychotic medication(s) other than risperidone, paliperidone, clozapine, ziprasidone, or thioridazine for at least 4 weeks prior to screening
- Clinically stable based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score ≤70 as well as a PANSS HATE (hostility, anxiety, tension and excitement) subtotal score <16 at screening
- Clinical Global Impression-Severity (CGI-S) score of 1 to 4, inclusive
- Body mass index (BMI) ≥17.0 and ≤37kg/m2; body weight ≥50 kg
- Creatinine level within the normal range
- All female patients (childbearing potential and non-childbearing potential) must have a negative pregnancy test result at both screening and baseline.
- Sexually active fertile male patients must be willing to use acceptable contraception methods (such as double barrier methods of a combination of male condom with either cap, diaphragm or sponge with spermicide) from study drug dosing, throughout the study, and for another 80 days after the EOT visit (or at least 200 days after the dose, whichever is longer) if their partners are women of childbearing potential.
Who cannot join
- Primary and active DSM-V Axis I diagnosis other than schizophrenia
- Patients who meet DSM-V criteria for substance abuse (moderate or severe) with the exception of caffeine or nicotine in the past 6 months prior to screening, or test positive for barbiturate or alcohol at screening or baseline
- Patients who received any of following treatment:
- Use of oral risperidone or paliperidone within 2 weeks before screening.
- Use of clozapine, thioridazine or ziprasidone within 4 weeks before screening.
- Use of 2-week depot formulation of risperidone within 3 months, 1-month depot formulation of risperidone or 9-hydroxy risperidone (INVEGA SUSTENNA) within 1 year,
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- Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, or any of their excipients (oral risperidone tolerability test should be completed during the screening period
- QTcF interval greater than 450 msec for males and 470 msec for females or a prior history or presence of circumstances
- Medical history (within 2 years) of clinically significant, gastrointestinal, cardiovascular, cerebrovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, neurologic, immunologic disorders, or drug hypersensitivity which, in the judgement of the Investigator, would interfere with the patient's ability to participate in the study
- History of dementia-related psychosis or Parkinson's Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Hassman Research Institute
Berlin, New Jersey, 08009
About this study
Official title: A Randomized, Open-Label, Parallel, Single-Dose Study to Evaluate the Pharmacokinetic Characteristics of LY03010 Process 1 and Process 2 Drug Product Versus INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level.
Read the detailed description
This is a randomized, open-label, parallel-group, single-dose study. Patients will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. About 36 patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups. Patients will be admitted to the clinical facility the day before dosing (Day 0) and will be receiving an IM injection of study drug and completing the assigned study activity including PK sample collection on Day 1. Patients will be discharged on Day 2 after PK collection. All patients will return to the clinical site at designated study days for PK sample collections and assigned clinical procedures. End of study evaluation will be completed on Day 120.
Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.
- Conditions
- Schizophrenia Patients
- Being tested
- Paliperidone Palmitate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone PalmitateDrug
Also called Paliperidone Injectable Product
A long acting extended release injectable suspension intended for monthly intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| LY03010 Process 1 | Experimental | Drug Product of Process 1 ( P1): 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study.
LY03010 P1 using a non-sterile Active Pharmaceutical Ingredients (API) with an absolute ethanol recrystallization was manufactured by an optimized production process Receives: Drug: Paliperidone Palmitate |
| LY03010 Process 2 | Experimental | Drug Product of Process 2 (P2): 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study.
LY03010 P2 using a sterile Active Pharmaceutical Ingredients (API) with an isopropanol recrystallization was manufactured by the same optimized production process as that used in P1. Receives: Drug: Paliperidone Palmitate |
| INVEGA SUSTENNA | Experimental | INVEGA SUSTENNA 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study Receives: Drug: Paliperidone Palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the Maximum Plasma Concentration [Cmax]of LY03010 P1, P2 and INVEGA SUSTENNA following a single IM injection of 156 mg dosage level in schizophrenia patients
The Cmax of LY03010 P1, P2 and INVEGA SUSTENNA will be measured
Measured: 120-Day
To characterize Area under the plasma concentration versus time curve (AUC) of LY03010 P1 and P2 and INVEGA SUSTENNA following a single IM injection of 156 mg dosage level in schizophrenia patients.
The AUCs of LY03010 P1, P2 and INVEGA SUSTENNA will be evaluated
Measured: 120-Day
To compare the Cmax of LY03010 P1 and P2 with the Cmax of INVEGA SUSTENNA
The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed
Measured: 120-Day
To compare the AUCs of LY03010 P1 and P2 with the AUCs of INVEGA SUSTENNA
The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed
Measured: 120-Day
Secondary outcomes (6)
To evaluate the safety and tolerability of tested drugs. Safety assessments include Incidence of adverse events.
AE will be monitored throughout of the study course
Measured: 120 day
To evaluate the safety of the tested drugs-- Incident of abnormal vital sign
Vital Sign will be measured on Day1 ,2, 4, 6, 8,10,12,15, 17,19, 22 ,29, 64, 92 and Day 120
Measured: 120 Day
To evaluate the safety of the tested drugs-- Incident of abnormal ECG Findings
12-Lead ECG will be measured on Day 0, 29, 64, 92 and Day 120
Measured: 120 Day
To evaluate any abnormal movement symptoms measured by Abnormal Involuntary Movement Scale (AIMS). AIMS measures movement of each part of body muscle with score range of 0-4, 0 means None and 4 means Severe.
AIMS will be measured on Day 0, 15, 29, 64, 92 and Day 120
Measured: 120-Day
To evaluate any abnormal movement symptoms measured by Barnes Akathisia Rating Scale (BARS). BARS is a rating scale for drug-induced akathisia with a range of 0-14; 0 means Normal and 14 means Severe.
BARS will be measured on Day 0, 15, 29, 64, 92 and Day 120
Measured: 120-Day
To evaluate any suicidal attempts measured by Columbia Suicide Severity Rating Scale ( C-SRRS). C-SRRS measures the suicidal intensity of ideation and attempt with score of 1-5; 1 means the least severe and 5 means the most severe.
C-SSRS will be measured on Day 0, 29, 64, 92 and Day 120
Measured: 120-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start22 Jan 2020
- Primary completion26 Jun 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia PatientsStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single dose study in three parallel dosing groups of schizophrenia patients
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alliance for Clinical Trials in Oncology, Evolution Research Group
- Responsible party
- Sponsor
- Investigators
- Luye Pharma, Study chair, Luye Pharma Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572685
- Sponsor's protocol ID
- LY03010/CT-USA-102
- Status last verified
- Nov 2020
- First submitted
- 8 May 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Hu L, Meyer JM, Citrome L, Song H, Wang S, Liu P, Yang JJ, Dong Y. Population Pharmacokinetics and Dosing Simulations for Paliperidone Palmitate 351 mg as Alternative Maintenance Doses in Patients With Schizophrenia or Schizoaffective Disorder. J Clin Psychiatry. 2026 Sep 16;87(4):26m16416. doi: 10.4088/JCP.26m16416.
PubMed 42752599
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel, Single-Dose Study to Evaluate the Pharmacokinetic Characteristics of LY03010 Process 1 and Process 2 Drug Product Versus INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT04572685
- Acronym / sponsor ID
- LY03010/CT-USA-102
- Conditions
- Schizophrenia Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Alliance for Clinical Trials in Oncology, Evolution Research Group
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level.
Detailed description
This is a randomized, open-label, parallel-group, single-dose study. Patients will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. About 36 patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups. Patients will be admitted to the clinical facility the day before dosing (Day 0) and will be receiving an IM injection of study drug and completing the assigned study activity including PK sample collection on Day 1. Patients will be discharged on Day 2 after PK collection. All patients will return to the clinical site at designated study days for PK sample collections and assigned clinical procedures. End of study evaluation will be completed on Day 120.
Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A single dose study in three parallel dosing groups of schizophrenia patients
| Arm | Type | Receives |
|---|---|---|
| LY03010 Process 1 | Experimental | Drug: Paliperidone PalmitateDrug Product of Process 1 ( P1): 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study. LY03010 P1 using a non-sterile Active Pharmaceutical Ingredients (API) with an absolute ethanol recrystallization was manufactured by an optimized production process |
| LY03010 Process 2 | Experimental | Drug: Paliperidone PalmitateDrug Product of Process 2 (P2): 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study. LY03010 P2 using a sterile Active Pharmaceutical Ingredients (API) with an isopropanol recrystallization was manufactured by the same optimized production process as that used in P1. |
| INVEGA SUSTENNA | Experimental | Drug: Paliperidone PalmitateINVEGA SUSTENNA 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥18 to ≤65 years of age who meets diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for at least 1 year before screening
- Have been on a stable dose of oral antipsychotic medication(s) other than risperidone, paliperidone, clozapine, ziprasidone, or thioridazine for at least 4 weeks prior to screening
- Clinically stable based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score ≤70 as well as a PANSS HATE (hostility, anxiety, tension and excitement) subtotal score <16 at screening
- Clinical Global Impression-Severity (CGI-S) score of 1 to 4, inclusive
- Body mass index (BMI) ≥17.0 and ≤37kg/m2; body weight ≥50 kg
Key exclusion criteria (10 listed)
- Primary and active DSM-V Axis I diagnosis other than schizophrenia
- Patients who meet DSM-V criteria for substance abuse (moderate or severe) with the exception of caffeine or nicotine in the past 6 months prior to screening, or test positive for barbiturate or alcohol at screening or baseline
- Patients who received any of following treatment:
- Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, or any of their excipients (oral risperidone tolerability test should be completed during the screening period
- QTcF interval greater than 450 msec for males and 470 msec for females or a prior history or presence of circumstances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paliperidone PalmitateAlso: Paliperidone Injectable ProductA long acting extended release injectable suspension intended for monthly intramuscular administration | Drug | INVEGA SUSTENNA, LY03010 Process 1, LY03010 Process 2 |
Primary outcome
To characterize the Maximum Plasma Concentration [Cmax]of LY03010 P1, P2 and INVEGA SUSTENNA following a single IM injection of 156 mg dosage level in schizophrenia patients
Time frame: 120-Day
The Cmax of LY03010 P1, P2 and INVEGA SUSTENNA will be measured
To characterize Area under the plasma concentration versus time curve (AUC) of LY03010 P1 and P2 and INVEGA SUSTENNA following a single IM injection of 156 mg dosage level in schizophrenia patients.
Time frame: 120-Day
The AUCs of LY03010 P1, P2 and INVEGA SUSTENNA will be evaluated
To compare the Cmax of LY03010 P1 and P2 with the Cmax of INVEGA SUSTENNA
Time frame: 120-Day
The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed
To compare the AUCs of LY03010 P1 and P2 with the AUCs of INVEGA SUSTENNA
Time frame: 120-Day
The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed
6 secondary outcomes
To evaluate the safety and tolerability of tested drugs. Safety assessments include Incidence of adverse events.
Time frame: 120 day
To evaluate the safety of the tested drugs-- Incident of abnormal vital sign
Time frame: 120 Day
To evaluate the safety of the tested drugs-- Incident of abnormal ECG Findings
Time frame: 120 Day
To evaluate any abnormal movement symptoms measured by Abnormal Involuntary Movement Scale (AIMS). AIMS measures movement of each part of body muscle with score range of 0-4, 0 means None and 4 means Severe.
Time frame: 120-Day
To evaluate any abnormal movement symptoms measured by Barnes Akathisia Rating Scale (BARS). BARS is a rating scale for drug-induced akathisia with a range of 0-14; 0 means Normal and 14 means Severe.
Time frame: 120-Day
To evaluate any suicidal attempts measured by Columbia Suicide Severity Rating Scale ( C-SRRS). C-SRRS measures the suicidal intensity of ideation and attempt with score of 1-5; 1 means the least severe and 5 means the most severe.
Time frame: 120-Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 42752599Chen Y, Hu L, Meyer JM, Citrome L, Song H, Wang S, Liu P, Yang JJ, Dong Y. Population Pharmacokinetics and Dosing Simulations for Paliperidone Palmitate 351 mg as Alternative Maintenance Doses in Patients With Schizophrenia or Schizoaffective Disorder. J Clin Psychiatry. 2026 Sep 16;87(4):26m16416. doi: 10.4088/JCP.26m16416.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luye Pharma study chair
Luye Pharma Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paliperidone Palmitate in people with Schizophrenia Patients, run by Luye Pharma Group Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the Maximum Plasma Concentration [Cmax]of LY03010 P1, P2 and INVEGA SUSTENNA following a single IM injection of 156 mg dosage level in schizophrenia patients (time frame: 120-Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.