NCT05298306

A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Lateral Pharma Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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. 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. Subjects in Part A are randomized to receive placebo and LAT8881 according to the following treatment sequences. Two subjects are allocated to each treatment sequence, a total of eight subjects overall. 0.8 mg/kg/1.2 mg/kg/1.8 mg/kg; 0.8 mg/kg/1.2 mg/kg/Placebo; 0.8 mg/kg/Placebo/1.8 mg/kg; Placebo/1.2 mg/kg/1.8 mg/kg. 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 either a 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.

Conditions

• Radiculopathy Lumbar

Interventions

Type	Name	Description
DRUG	LAT8881	In Part A, LAT8881 will be given as a single intravenous infusion at doses of 0.8, 1.2 and 1.8 mg/kg. In Part B, a single intravenous infusion of LAT8881 will be given, the dose to be determined by the results in Part A
DRUG	Placebo	Matching placebo'given as a single intravenous infusion at all dose levels

Timeline

• Start date: 2022-05-17
• Primary completion: 2023-05-12
• Completion: 2023-06-16
• First posted: 2022-03-28
• Last updated: 2024-11-27
• Results posted: 2024-11-27

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study