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

NCT06980207 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-20

No results posted yet for this study

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

Interventions

DRUG

LY03017

administered orally

DRUG

LY03017-Placebo

administered orally

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06980207 on ClinicalTrials.gov