At a glance
ClinicalIndex Comparison Record- ✓Part A: Healthy participants aged 18–49 years
- ✓Part B: Unilateral radicular pain radiating to lower limb with lancinating, burning, stabbing, or electric quality, lasting >3 months
- ✓Part B: Pain score (NRS) ≥4/10 mean and ≤9/10 for average daily leg pain at rest over 3 days pre-treatment, with minimum >3/10 on any day
- ✓Part B: Disc herniation confirmed within 6 months by CT or MRI at segmental level L1–2, L2–3, L3–4, L4–5, or L5–S1 consistent with clinical features
- ✕Part A and B: Any condition that might pose a safety risk or interfere with study evaluation
- ✕Part A and B: Unwillingness to abstain from alcohol or nicotine products as required
- ✕Part B: History of significant pain unrelated to disc herniation that would compromise assessment of leg radicular pain
- ✕Part B: Radiological evidence of foraminal stenosis or clinically significant spinal stenosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
In Brief
A Phase 1 clinical trial evaluating LAT8881 and Placebo for Radiculopathy Lumbar. Completed, enrolled 26 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
Matching placebo'given as a single intravenous infusion at all dose levels