Status:
COMPLETED
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
Lead Sponsor:
Lateral Pharma Pty Ltd
Collaborating Sponsors:
Southern Star Research
Conditions:
Radiculopathy Lumbar
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 effi...
Detailed Description
Part A of this study is a double-blind, randomized, placebo-controlled, single ascending dose study of intravenous administration of LAT8881 over 5 minutes in healthy volunteers. Each participant has ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05298306
Start Date
May 17 2022
End Date
June 16 2023
Last Update
November 27 2024
Active Locations (1)
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1
PARC Clinical Research
Adelaide, South Australia, Australia, 5000