MedTrace Logo

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

NCT05298306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-11-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Radiculopathy Lumbar

Interventions

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

Sponsors & Collaborators

  • Southern Star Research

    collaborator INDUSTRY

  • Lateral Pharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Guy Ludbrook, MBBS · Royal Adelaide Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2023-05-12
Completion
2023-06-16
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298306 on ClinicalTrials.gov