A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral LPM526000133 Fumarate Capsules (LY03017) in Healthy Adult Subjects.

This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Negative Symptoms of Schizophrenia; Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis; Hallucinations and Delusions Associated With Parkinson Disease Psychosis
• Intervention / Treatment: Drug: LY03017; Drug: LY03017-Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huafang Li; Phone Number: 021-34773107 +8618017311256; Email: lhlh_5@163.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Mental Health Center
    • Contact: Huafang Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject who voluntarily participate and sign the informed consent form.
• Healthy male/female volunteers aged ≥18 and ≤ 45 years.
• Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 26.0 kg/m2.
• Able to comply with the lifestyle restrictions.

Exclusion Criteria:

• Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
• Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results.
• Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
• Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
• Subject has abnormal vital signs, laboratory abnormalities, and ECGs.
• Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
• Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).
• Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.
• Subject has a history of substance abuse within 1 year or a positive urine drug screen.
• Subject who has daily smoking of ≥ 5 cigarettes within 3 months.
• Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.
• Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.
• Subject who has participated in other clinical trials within 3 months before administration.
• Subject has used blood products or being blood donor or blood loss within 3 months.
• Pregnant, lactating women, or positive pregnancy test.
• Subject who refusal to contraception, or plan to donate sperm or ovums.
• Subject who has a history of needle or blood faintness.
• Subject directly involved in this clinical trial.
• Poor compliance or other conditions which would make participation in the study unsuitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY03017; Ascending single oral doses of LY03017 in healthy adult subjects	Drug: LY03017; single dose, administered orally; Other Names: LPM526000133 Fumarate Capsules
Placebo Comparator: Placebo; LY03017-Placebo	Drug: LY03017-Placebo; single dose, administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	up to 216 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax) of LPM526000133 in plasma	up to 216 hours
Time to maximum observed concentration (Tmax) of LPM526000133 in plasma	up to 216 hours
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma	up to 216 hours
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma	up to 216 hours
Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma	up to 216 hours

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Perceptual Disorders; Schizophrenia; Psychotic Disorders; Parkinson Disease; Mental Disorders; Alzheimer Disease; Hallucinations; Delusions
• Other Study ID Numbers: LY03017/CT-CHN-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No