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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 3 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.