LBT-3627 for Parkinson's (NCT06466525)
Test drug safety in Parkinson
- Trial ID
- NCT06466525
- Official Title
- A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.
- Goal
- Test drug safety in Parkinson
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Longevity Biotech Australia Pty Ltd (subsidiary)
- Study Type
- INTERVENTIONAL
- Enrollment
- 64 participants
- Conditions
- Parkinson Disease
- Interventions
- LBT-3627, Placebo
Summary For Families
The goal is to check whether LBT-3627 is safe and produces early biological effects that might be helpful for Parkinson's. LBT-3627 is an experimental drug given in single and multiple increasing doses so researchers can measure how the body absorbs and clears it and whether it has measurable pharmacodynamic effects; people taking levodopa must be on a stable dose and can briefly withhold it for on-site assessments so any interactions can be seen. The Phase 1 trial plans to enroll up to 64 adults aged 30 to 89, including healthy volunteers and people with Parkinson's diagnosed 1,10 years ago with mild to moderate disease (Hoehn and Yahr 1,3). Major heart, liver, kidney, immune or psychiatric problems, recent infections or certain recent medications will exclude people, so check with the study team to see if you qualify.
Locations
- Alfred Hospital, Melbourne, Victoria, Australia
- Nucleus Networks, Melbourne, Victoria, Australia
Frequently Asked Questions
- What is this trial testing?
- This trial is studying LBT-3627. The goal is to check whether LBT-3627 is safe and produces early biological effects that might be helpful for Parkinson's. LBT-3627 is an experimental drug given in single and multiple increasing doses so researchers can measure how the body absorbs and clears it and whether it has measurable pharmacodynamic effects; people taking levodopa must be on a stable dose and can briefly withhold it for on-site assessments so any interactions can be seen. The Phase 1 trial plans to enroll up to 64 adults aged 30 to 89, including healthy volunteers and people with Parkinson's diagnosed 1,10 years ago with mild to moderate disease (Hoehn and Yahr 1,3). Major heart, liver, kidney, immune or psychiatric problems, recent infections or certain recent medications will exclude people, so check with the study team to see if you qualify.
- Who can participate?
- Participants must be between 30 Years and 89 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 3 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.