Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05298306
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2022-03-03
Brief Title:
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
Sponsor:
Lateral Pharma Pty Ltd
Organization:
Lateral Pharma Pty Ltd
Study Overview
Official Title:
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
Status:
COMPLETED
Status Verified Date:
2023-07
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:
The study consists of two parts Part A will evaluate the safety and tolerability of intravenous LAT8881 in healthy volunteers using an ascending dose schedule Part B will evaluate the analgesic efficacy of a single intravenous dose of LAT8881 compared with placebo in patients with lumbar radicular pain
Healthy volunteers are not accepted for Part B
Healthy volunteers are not accepted for Part B
Detailed Description:
Part A of this study is a double-blind randomized placebo-controlled single ascending dose study of intravenous administration of LAT8881 over 5 minutes in healthy volunteers Eight participants will be enrolled Each participant has three treatment days 1 infusion per dosing day on Days 1 4 and 7 as well as two short visits for safety blood sampling on Days 3 and 6 Participants are randomised so on each treatment day 6 participants receive LAT8881 and 2 receive placebo different participants to receive placebo each treatment day LAT8881 doses administered are 08 mgkg on Day 1 12 mgkg on Day 4 and 18 mgkg on Day 7
Part B of this study is is a placebo-controlled randomized double blind cross-over safety and efficacy study of LAT8881 in up to 20 patients with lumbar radicular pain Participants will be randomly assigned to one of two groups to receive either LAT8881 then placebo or placebo then LAT8881 Participants will receive a either single dose of LAT8881 the Maximum Tolerated Dose from Part A of the study or placebo via intravenous administration over 5 minutes on two consecutive days
Part B of this study is is a placebo-controlled randomized double blind cross-over safety and efficacy study of LAT8881 in up to 20 patients with lumbar radicular pain Participants will be randomly assigned to one of two groups to receive either LAT8881 then placebo or placebo then LAT8881 Participants will receive a either single dose of LAT8881 the Maximum Tolerated Dose from Part A of the study or placebo via intravenous administration over 5 minutes on two consecutive days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None