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.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 89
Healthy Volunteers: t
View:
• Male or female, 30-89 years inclusive at screening
• BMI 18-32 kg/m²
• Vital signs, ECG (QTcF \<450 ms male / \<470 ms female), and safety labs without clinically significant abnormality; no orthostatic hypotension
• Women of non-childbearing potential, or using highly effective contraception per protocol
Locations
Other Locations
Australia
Alfred Hospital
RECRUITING
Melbourne
Nucleus Networks
ACTIVE_NOT_RECRUITING
Melbourne
Contact Information
Primary
Tim Porter, MBBS, FANZCA, MBioethics
Tim.Porter@avancecro.com
+61 450992172
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2027-02
Participants
Target number of participants: 64
Treatments
Experimental: Healthy Volunteers - SAD
Single dose of LBT-3627 administered to healthy volunteers
Experimental: Parkinson's disease patients - SAD
Single dose of LBT-3627 administered to Parkinson's disease patients
Experimental: Parkinson's disease patients - MAD
Multiple doses of LBT-3627 administered to Parkinson's disease patients
Related Therapeutic Areas
Sponsors
Leads: Longevity Biotech Australia Pty Ltd (subsidiary)