Phase 1
N=26
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
Radiculopathy Lumbar
Bottom Line
View on ClinicalTrials.gov: NCT05298306 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: The Number of Participants With Adverse Events by Dose (Part A) — 1; 1; 2; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LAT8881 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lateral Pharma Pty Ltd
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Adverse Events by Dose (Part A) |
1; 1; 2; 2; 0; 0 | — |
| PRIMARY Change in Baseline Pain With Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B) |
3.7; 3.1; -0.8; -0.3; -0.8; -0.3 | 0.5196 |
| SECONDARY Maximum Plasma LAT8881 Concentration (Cmax) After Intravenous LAT8881 (Part A) |
12.6; 10.2; 13.8 | — |
| SECONDARY Time to Maximum Plasma LAT8881 Concentration (Tmax) After Intravenous LAT8881 (Part A) |
0.08; 0.08; 0.08 | — |
| SECONDARY Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) After Intravenous LAT8881 (Part A) |
NA; NA; NA | — |
| SECONDARY Terminal Elimination Half Life (T1/2), (Part A) |
NA; NA; NA | — |
| SECONDARY Patient General Impression of Change (Part B) |
2; 0; 3; 2; 4; 11 | — |
| SECONDARY The Number of Participants With Adverse Events After Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B) |
5; 4; 0; 0; 0; 0 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT05298306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.