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

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 years and above at screening;
• Body mass index of ≥ 19.0 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.
• Pain scores (NRS) 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 disc herniation within 6 months by CT or MRI at a segmental level consistent with the clinical features.
• The site of 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.
• 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.