Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565195
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Sponsor-unblinded Placebo-controlled Single-ascending-dose Study in Healthy Volunteers and a Double-blind Sponsor-unblinded Placebo-controlled Multiple-ascending-dose Study in Patients With Parkinsons Disease to Evaluate the Safety Tolerability and PKPD of LY3962681
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSPECT
Brief Summary:
The purpose of this study is to evaluate the safety tolerability and PKPD of LY3962681 in healthy volunteers and patients with Parkinsons disease
The study will be comprised of two parts the Single Ascending Dose SAD study and the Multiple Ascending Doses MAD study During the SAD portion of the study healthy volunteers will receive a single dose of LY3962681 or placebo no active drug given into the spinal fluid During the MAD portion of the study patients with Parkinsons disease will receive two doses of either LY3962681 or placebo administered into the spinal fluid
The treatment period in the SAD study will be 1 day The treatment period in the MAD study will be 2 days 12 to 24 weeks apart
The follow-up period in the SAD study will be up to 52 weeks The follow-up period in the MAD study will be up to 52 weeks post Dose 2
The study will be comprised of two parts the Single Ascending Dose SAD study and the Multiple Ascending Doses MAD study During the SAD portion of the study healthy volunteers will receive a single dose of LY3962681 or placebo no active drug given into the spinal fluid During the MAD portion of the study patients with Parkinsons disease will receive two doses of either LY3962681 or placebo administered into the spinal fluid
The treatment period in the SAD study will be 1 day The treatment period in the MAD study will be 2 days 12 to 24 weeks apart
The follow-up period in the SAD study will be up to 52 weeks The follow-up period in the MAD study will be up to 52 weeks post Dose 2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None