Actively Recruiting
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.
Led by Longevity Biotech Australia Pty Ltd (subsidiary) · Updated on 2025-05-13
64
Participants Needed
2
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent and understand the study risks and purpose
- Healthy men or women aged 30 to 89 years
- Body mass index between 18 and 32 kg/m2
- Physical exam without significant findings
- Systolic blood pressure 90-140 mmHg and diastolic 40-90 mmHg after rest and standing; no orthostatic hypotension
- Heart rate 50-100 beats per minute after rest and standing; no orthostatic hypotension
- Body temperature between 35.5°C and 37.5°C
- ECG without significant abnormalities including QTcF <450 ms for males and <470 ms for females
- No clinically significant lab abnormalities
- Women must be non-childbearing or meet strict pregnancy prevention requirements
- Men must agree to use contraception or abstain from sperm donation during the study
- Willingness and ability to comply with all study requirements
- For Parkinson's patients: diagnosis confirmed 1-10 years ago, Hoehn and Yahr score 1-3, stable or no levodopa therapy as specified
You will not qualify if you...
- Use of immunomodulators within 60 days before first dose unless approved
- Use of coenzyme Q10 within 5 days before first dose
- Vaccination within 60 days before first dose
- History of allergy or severe reaction to study drug ingredients
- Stroke, transient ischemic attack, or unexplained loss of consciousness within 12 months
- Active SARS-CoV-2 infection or long-COVID prior to screening
- Significant diseases or disorders that may interfere with study or pose risk
- Surgery or hospitalization within 12 weeks prior or planned during study
- Unsuitable veins for blood sampling
- Tattoos or scarring interfering with injection site assessments
- Inadequate kidney or liver function based on lab tests
- Active infection requiring treatment within 14 days prior to dosing
- Concurrent participation in another clinical study or recent participation within 90 days
- Excessive alcohol consumption or positive alcohol/drug tests at screening
- Smoking more than 5 cigarettes per week or unwilling to abstain during confinement
- Use of cannabis or THC within 90 days prior to dosing
- Pregnant, breastfeeding, or planning pregnancy during study
- Known substance abuse or conditions interfering with participation
- Positive tests for Hepatitis B, Hepatitis C, or HIV
- Recent blood donation, significant blood loss, or transfusion
- Parkinson's patients: antibiotic use within 30 days, use of certain supplements or biologics, history of brain surgery or neuromodulation, frequent falls, prostate carcinoma, and other specified conditions or recent surgeries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Alfred Hospital
Melbourne, Victoria, Australia
Actively Recruiting
2
Nucleus Networks
Melbourne, Victoria, Australia
Active, Not Recruiting
Research Team
T
Tim Porter, MBBS, FANZCA, MBioethics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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