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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lateral Pharma Pty Ltd
• Collaborator: Southern Star Research

Criteria

Key Inclusion Criteria:

For PART A, the following inclusion criteria apply:

• Male or female healthy participants, aged 18-49 years inclusive at screening;

• Body mass index of ≥ 19.0 kg/m2 to ≤ 32.0 kg/m2 at screening;

• Female participants must not be pregnant or breastfeeding

• Male participants with a female partner of childbearing potential must use highly effective contraception for 60 days after the last dose of study treatment

For PART B, the following key inclusion criteria apply:

• Male or female participants with unilateral pain, aged 18-65 years inclusive at screening;

• Body mass index of ≥ 19.0 kg/m2 to ≤ 35.0 kg/m2 at screening.

• Female participants must not be pregnant or breastfeeding

• Male participants with a female partner of childbearing potential must use highly effective contraception for 60 days after the last dose of study treatment

• Presenting with a history of unilateral pain, radiating into a lower limb, of lancinating, burning, stabbing or electric quality, of duration of 3 months to 12 months.

• Pain scores (VAS) for average daily leg pain at rest at the relevant nerve root of a mean of ≥4/10 and ≤9/10 for 3 days prior to treatment, with a minimum of >3/10 on any day.

• Demonstration of a disc herniation within 6 months by CT or MRI at a segmental level consistent with the clinical features.

• The site of the disc herniation must affect L1-2, L2-3, L3-4, L4-5 or L5-S1.

• The patient is willing to keep all analgesic medication and other therapy usage stable or decreased in the week prior to, and a week after, IP administration.

• The patient is in good general health, with the exception of the presenting condition under study

Key Exclusion Criteria:

The following key exclusion criteria apply for both PART A and PART B:

• Any condition which might be a risk to participant safety or interfere with study evaluation

• Unwillingness to abstain from alcohol or nicotine products as required

The following additional key exclusion criteria apply to PART B:

• A history of significant pain unrelated to disc herniation that would significantly compromise assessment of leg radicular pain.

• Clinical evidence of radicular pain at more than one spinal nerve.

• Radiological evidence of foraminal stenosis or of clinically significant spinal stenosis .

• Lumbar back surgery related to the specific disc.

• Injection of an epidural corticosteroid injection within 3 months of screening.