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

This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.

Registry numberNCT05298306
StatusCompleted
PhasePhase 1
SponsorLateral Pharma Pty Ltd
Enrollment26 participants
DesignInterventional, Randomized, Crossover, Masking: Quadruple
ConditionsRadiculopathy Lumbar
InterventionsLAT8881; Placebo
StartMay 17, 2022
Primary completionMay 12, 2023
Study completionJun 16, 2023
Results postedYes, in the registry
Registry last updatedNov 27, 2024
CollaboratorsSouthern Star Research

Compounds on this site that cite this trial

What the registry says the trial is about

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.

Primary outcomes

These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.

Outcome measureTime frame
The Number of Participants With Adverse Events by Dose (Part A)From first dose of LAT8881 to end of study visit (Day 14)
Change in Baseline Pain With Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)From start of infusion to 6 hours after start of infusion

6 secondary outcomes also registered. See the registry record for the full list.

Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.