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

NCT05298306 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: LAT-NP-002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Radiculopathy Lumbar

Outcome Measures

Primary Outcomes (2)

• The Number of Participants With Adverse Events by Dose (Part A)

  The number of participants in Part A with the following adverse events will be reported by dose (with all placebo subjects combined) * All adverse events * Serious adverse events * Adverse events leading to premature discontinuation of Investigational Medicinal Product (IMP) * Adverse events by intensity * Adverse events by relationship to IMP

  From first dose of LAT8881 to end of study visit (Day 14)

• Change in Baseline Pain With Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)

  Change in pain from baseline is measured on on a 0-10 Visual Analogue Scale (VAS). The VAS consists of a 10 cm line with two endpoints representing 0 (no pain) and 10 (pain as bad as it could possibly be). The subject is asked to rate their current level of pain by placing a mark on the line and the distance from 0 is measured to provide a pain intensity score out of 10. VAS measurements are taken as the infusion starts and at 15 minute intervals for the first hour, then every thirty minutes for an additional two hours, then hourly until 6 hours from infusion commencement

  From start of infusion to 6 hours after start of infusion

Secondary Outcomes (6)

• Maximum Plasma LAT8881 Concentration (Cmax) After Intravenous LAT8881 (Part A)

  Up to 6 hours after the start of each infusion

• Time to Maximum Plasma LAT8881 Concentration (Tmax) After Intravenous LAT8881 (Part A)

  Up to 6 hours after the start of each infusion

• Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) After Intravenous LAT8881 (Part A)

  Up to 6 hours after the start of each infusion

• Terminal Elimination Half Life (T1/2), (Part A)

  Up to 6 hours after the start of each infusion

• Patient General Impression of Change (Part B)

  6 hours after the start of each infusion

Other Outcomes (1)

• The Effect of LAT8881, Compared With Placebo, on VAS Pain Scores During a Straight-leg Nerve Stretch.

  From start of infusion to 6 hours after start of infusion

Study Arms (2)

LAT8881

EXPERIMENTAL

In Part A, LAT8881 will be given as a single intravenous infusion on separate days at doses of 0.8, 1.2 and 1.8 mg/kg. In Part B, LAT8881 will be given as a single intravenous infusion. The dose will be determined from the results of Part A.

Drug: LAT8881

Placebo

PLACEBO COMPARATOR

Matching placebo will be given as a single intravenous infusion in Part A and Part B

Drug: Placebo

Interventions

LAT8881 DRUG

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

LAT8881

Placebo DRUG

Matching placebo'given as a single intravenous infusion at all dose levels

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Lateral Pharma Pty Ltd: lead
• Southern Star Research: collaborator

Study Sites (1)

PARC Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Results Point of Contact

• Title: Dr Stuart Mudge
• Organization: Lateral Pharma

sm@lateral-pharma.com

+61424588904

Study Officials

• Guy Ludbrook, MBBS

  Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The crossover study (Part B) is preceded by a single ascending dose study (Part A)

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 28, 2022
• Study Start: May 17, 2022
• Primary Completion: May 12, 2023
• Study Completion: June 16, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)