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Antipsychotic

LY03010 351 mg treatment group, deltoid for Molecular Pharmacology

Phase 1
Recruiting
Research Sponsored by Luye Pharma Group Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) ≥17.0 and ≤37 kg/m2; body weight ≥50 kg.
For patients with schizoaffective disorder only: Young Mania Rating Scale (YMRS) ≤12 and Hamilton Rating Scale for Depression, 17-item version (HAM-D) ≤12.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 176 days
Awards & highlights

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.

Eligible Conditions
  • Molecular Pharmacology
  • Neurotransmitters
  • Psychotropic Medications
  • Drug Effects
  • Mental Illness
  • Mood Disorders
  • Schizophrenia
  • Antipsychotics
  • Tranquilizers
  • Central Nervous System Depression
  • Psychosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are male or female aged 18 to 65 years who meets diagnostic criteria for schizophrenia or schizoaffective disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~176 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 176 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic (PK) profiles of paliperidone in LY03010
Secondary outcome measures
Safety and tolerability of LY03010

Trial Design

4Treatment groups
Experimental Treatment
Group I: LY03010 351 mg treatment group, glutealExperimental Treatment1 Intervention
LY03010 (paliperidone palmitate) is a pharmaceutical equivalent drug product to the listed drug (LD) product INVEGA SUSTENNA®. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate. Its molecular formula is C39H57FN4O4 and its molecular weight is 664.89. LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection. In LY03010 treatment group, all subjects will receive the first dose of 351 mg IM injection on Day 1 in the gluteal muscle.
Group II: LY03010 351 mg treatment group, deltoidExperimental Treatment1 Intervention
LY03010 (paliperidone palmitate) is a pharmaceutical equivalent drug product to the listed drug (LD) product INVEGA SUSTENNA®. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate. Its molecular formula is C39H57FN4O4 and its molecular weight is 664.89. LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection. In LY03010 treatment group, all subjects will receive the first dose of 351 mg IM injection on Day 1 in the deltoid muscle.
Group III: LY03010 156 mg treatment group, glutealExperimental Treatment1 Intervention
LY03010 (paliperidone palmitate) is a pharmaceutical equivalent drug product to the listed drug (LD) product INVEGA SUSTENNA®. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate. Its molecular formula is C39H57FN4O4 and its molecular weight is 664.89. LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection. In LY03010 treatment group, all subjects will receive the first dose of 156 mg IM injection on Day 1 in the gluteal muscle.
Group IV: LY03010 156 mg treatment group, deltoidExperimental Treatment1 Intervention
LY03010 (paliperidone palmitate) is a pharmaceutical equivalent drug product to the listed drug (LD) product INVEGA SUSTENNA®. The chemical name is (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate. Its molecular formula is C39H57FN4O4 and its molecular weight is 664.89. LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection. In LY03010 treatment group, all subjects will receive the first dose of 156 mg IM injection on Day 1 in the deltoid muscle.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Luye Pharma Group Ltd.Lead Sponsor
58 Previous Clinical Trials
8,486 Total Patients Enrolled
Rui Li, MDStudy ChairLuye Pharma US Ltd
1 Previous Clinical Trials
281 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Innovative Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
~23 spots leftby Mar 2025