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

NCT06388551 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-29

No results posted yet for this study

Summary

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.

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

single dose, administered orally

DRUG

LY03017-Placebo

single dose, administered orally

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2025-03-30
Completion
2025-03-30

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 NCT06388551 on ClinicalTrials.gov