drugset
drugset / Trial / NCT05298306

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

NCT05298306 ↗

Phase 1 Completed 26 enrolled Lateral Pharma Pty Ltd Southern Star Research · collab
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2022-05-17
Primary completion
2023-05-12
Completion
2023-06-16

Outcome

Missed primary endpoint

registry analysis (superiority test); LAT8881 vs Placebo; p = 0.5196; Mean Difference (Net) -0.25 (95% CI -1.02 to 0.52) NCT05298306 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject LAT8881 Protein / enzyme biologic 0.8 mg/kg Intravenous
Subject LAT8881 Protein / enzyme biologic 1.2 mg/kg Intravenous
Subject LAT8881 Protein / enzyme biologic 1.8 mg/kg Intravenous

Indications

radiculopathy