Phase 1 Parkinson's Disease Trial, Not Yet Recruiting NCT06793995 Sponsor: Luye Pharma Group Ltd. Condition: Parkinson's Disease
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Phase 1 Parkinson's Disease Trial, Not Yet Recruiting

NCT06793995
Not Yet Recruiting Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who are willing to take part and sign a consent form agreeing to participate.
  • Part A: Adults aged 18 to 45 years (male or female).
  • Part B: Adults aged 65 years or older (male or female).
  • People who weigh at least 50 kg (for men) or at least 45 kg (for women), and whose body mass index (BMI) is between 18.5 and below 28.0.
  • People who are able to follow the lifestyle rules required during the trial.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have had an allergic reaction to any ingredient in the trial drug or similar drugs, or who tend to have allergies in general.
  • Part A: People who have a history of significant health conditions that could affect the trial results, including conditions affecting the blood, heart and circulation, digestion, urinary system, breathing, nervous system, immune system, hormones, mental health, or metabolism, or who have had cancer.
  • Part B: People who have a history of significant health conditions that could affect the trial results across similar body systems; however, people with well-managed, long-term stable conditions (such as high blood pressure, type 2 diabetes, or high cholesterol) that are not expected to affect safety or trial results may not be excluded (confirm with trial site).
  • People who have had surgery or have a medical condition that could significantly affect how the body processes the drug, or that could put them at risk.
  • People with significantly abnormal results on vital signs, blood tests, or heart trace (ECG) tests — for example, a pulse below 55 or above 100 beats per minute, blood pressure outside the acceptable range, or a heart electrical measurement (QTc) of 450 milliseconds or more.
  • Part B: People with certain abnormal liver or kidney blood test results, specifically liver enzyme or bilirubin levels above 1.5 times the normal upper limit, or a kidney filtration rate below 60 mL/min/1.73 m².
  • Part A: People who have taken any non-prescription products in the 7 days before dosing, or any prescription medicines in the 28 days before dosing.
  • Part B: People who have taken any non-prescription products in the 7 days before dosing, or any prescription medicines in the 28 days before dosing, except for medicines being taken to manage well-controlled, long-term stable conditions.
  • People who have had surgery within the 3 months before the trial starts, have not fully recovered from a previous surgery, or have a planned surgery during the trial period.
  • People who test positive for hepatitis B, hepatitis C, HIV, or syphilis.
  • People who have had a problem with alcohol in the past year, or who test positive on a breath alcohol test.
  • People who have used recreational or illicit substances in the past year, or who test positive on a urine drug screen.
  • People who have smoked 5 or more cigarettes per day in the past 3 months.
  • People who have special dietary requirements, cannot follow the standardised diet provided during the trial, or have difficulty swallowing.
  • People who have eaten or drunk certain foods such as grapefruit, chocolate, coffee, or other caffeine-rich items in the 48 hours before dosing, or who have regularly consumed large amounts of tea, coffee, grapefruit juice, or caffeinated drinks over the past 3 months.
  • People who have taken part in another clinical trial within the 3 months before this trial starts.
  • People who have received blood products, donated blood, or had significant blood loss within the past 3 months.
  • People who are pregnant, breastfeeding, or who return a positive pregnancy test.
  • People who are unwilling to use contraception during the trial, or who plan to donate sperm or eggs during this time.
  • People who have a history of fainting at the sight of needles or blood.
  • People who are directly involved in running this clinical trial.
  • People who are unlikely to follow the trial requirements, or who have other circumstances that would make participation unsuitable (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 7 July 2026

Contact this trial

Phone: 021-34773107

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Luye Pharma Group Ltd.
Registry
ClinicalTrials.gov
Start date
1 February 2025
Est. completion
31 October 2025

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Maximum observed concentration (Cmax) of LPM526000133 in plasma; The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma; Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov