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

NCT06980207 | Not Yet Recruiting Phase 1

• 1 other identifier: LY03017/CT-CHN-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis; Hallucinations and Delusions Associated With Parkinson Disease Psychosis; Negative Symptoms of Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  up to day 9

Secondary Outcomes (7)

• Maximum observed concentration at steady state (Cmax,ss) of LPM526000133 in plasma

  up to day 9

• Time to maximum observed concentration at steady state (Tmax,ss) of LPM526000133 in plasma

  up to day 9

• Minimum observed concentration at steady state (Cmin,ss) of LPM526000133 in plasma

  up to day 9

• Area Under the Concentration-Time Curve from Time Zero to Tau over a Dosing Interval at Steady State(AUC0-τ,ss）of LPM526000133 in plasma

  up to day 9

• The area under the concentration-time curve from time zero extrapolated to infinity at steady state (AUC0-∞,ss) of LPM526000133 in plasma

  up to day 9

Study Arms (2)

LY03017

EXPERIMENTAL

LY03017 will be administrated with multiple doses from 10mg to 40mg on day 1\~5

Drug: LY03017

LY03017-Placebo

PLACEBO COMPARATOR

Placebo will be administrated with multiple doses on day 1\~5.

Drug: LY03017-Placebo

Interventions

LY03017 DRUG

administered orally

LY03017

LY03017-Placebo DRUG

administered orally

LY03017-Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \< 28.0 kg/m2.
• Able to comply with the lifestyle restrictions.

You may not qualify if:

• Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
• Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.
• 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 clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as Pulse \< 55 beats/min or \> 100 beats/min, Systolic blood pressure \< 90 mmHg or ≥140 mmHg, Diastolic blood pressure \< 60 mmHg or ≥90 mmHg.
• QT interval (QTc) ≥450 ms (Male) or 460 ms (Female) .
• Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
• 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 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Hallucinations

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CN (1)