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Status unknownNCT06388551Updated Apr 29, 2024

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

A Phase 1 interventional study of LY03017 and LY03017-Placebo in Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis and Negative Symptoms of Schizophrenia, sponsored by Luye Pharma Group Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

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

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03

In context

Hallucinations

135 studies on the registry are indexed under Hallucinations; 36 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 115 interventional studies indexed under Hallucinations.

Browse Hallucinations studies →

Lead sponsor

Luye Pharma Group Ltd. is the lead sponsor of 74 studies on the registry; 15 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    LY03017

    Ascending single oral doses of LY03017 in healthy adult subjects

    Drug: LY03017

  • Placebo comparator
    Placebo

    LY03017-Placebo

    Drug: LY03017-Placebo

Interventions

  • single dose, administered orally

    Also known as: LPM526000133 Fumarate Capsules

  • DrugLY03017-Placebo

    single dose, administered orally

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: up to 216 hours

Secondary outcomes

  1. Maximum observed concentration (Cmax) of LPM526000133 in plasma

    Time frame: up to 216 hours

  2. Time to maximum observed concentration (Tmax) of LPM526000133 in plasma

    Time frame: up to 216 hours

  3. The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma

    Time frame: up to 216 hours

  4. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma

    Time frame: up to 216 hours

  5. Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma

    Time frame: up to 216 hours

07

Study locations

1 site
  • Shanghai Mental Health Center
    Shanghai, China
    • Huafang Li · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2024; primary completion for Mar 2025, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
Apr 29, 2024
StartEst.
May 10, 2024
Primary completionEst.
Mar 30, 2025
CompletionEst.
Mar 30, 2025
Last update
Apr 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06388551
Responsible party
Sponsor
First posted
Apr 29, 2024
Start date
May 10, 2024 (estimated)
Primary completion
Mar 30, 2025 (estimated)
Completion
Mar 30, 2025 (estimated)
Last update
Apr 29, 2024

Study contacts

Huafang Li
Contact
lhlh_5@163.com
+8618017311256 ext. 021-34773107

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: LY03017

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