Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466525
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-10
Brief 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 Parkinsons Disease
Sponsor:
Longevity Biotech Australia Pty Ltd subsidiary
Organization:
Longevity Biotech
Study Overview
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 Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I ab SADMAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinsons patients
Detailed Description:
Evaluate the safety and tolerability of LBT-3627 in both a single and multiple ascending dose study
Phase Ia will explore safety and tolerability first in healthy volunteers then followed by Parkinsons patients after a single dose Dose levels will escalate per cohort
Phase Ib will explore safety and tolerability in Parkinsons patients after multiple doses Dose levels will escalate per cohort
Phase Ia will explore safety and tolerability first in healthy volunteers then followed by Parkinsons patients after a single dose Dose levels will escalate per cohort
Phase Ib will explore safety and tolerability in Parkinsons patients after multiple doses Dose levels will escalate per cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None