Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT05298306Other idLAT-NP-002

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 26 participants (actual)
Sponsor: Lateral Pharma Pty Ltd · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
Australia
Start: 17 May 2022
Primary completion: 12 May 2023
Completion: 16 Jun 2023
First posted: 28 Mar 2022
Last update posted: 27 Nov 2024
Conditions: Radiculopathy Lumbar

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024

Ph 1
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
NCT05298306
17 May 2022 to 16 Jun 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LAT8881Drug
PlaceboDrug

Arms2

Experimental
LAT8881
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.
Placebo comparator
Placebo
Matching placebo will be given as a single intravenous infusion in Part A and Part B

Primary outcomes2

Outcomes the sponsor listed as primary.

The Number of Participants With Adverse Events by Dose (Part A)
Time frame · From first dose of LAT8881 to end of study visit (Day 14)
Registry description
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
Change in Baseline Pain With Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)
Time frame · From start of infusion to 6 hours after start of infusion
Registry description
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

Secondary outcomes(6)

Maximum Plasma LAT8881 Concentration (Cmax) After Intravenous LAT8881 (Part A)
Time frame · Up to 6 hours after the start of each infusion
Registry description
LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration
Time to Maximum Plasma LAT8881 Concentration (Tmax) After Intravenous LAT8881 (Part A)
Time frame · Up to 6 hours after the start of each infusion
Registry description
LAT8881 was measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration
Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) After Intravenous LAT8881 (Part A)
Time frame · Up to 6 hours after the start of each infusion
Registry description
LAT8881 was measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration. (AUC0-inf) was calculated only if there were at least three quantifiable data points.
Terminal Elimination Half Life (T1/2), (Part A)
Time frame · Up to 6 hours after the start of each infusion
Registry description
LAT8881 was measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration. The terminal elimination half life was only determined if there were at least three quantifiable elimination phase data points.
Patient General Impression of Change (Part B)
Time frame · 6 hours after the start of each infusion
Registry description
The Patient General Impression of Change (PGIC) is a single-item rating by subjects of their improvement with treatment during a clinical trial. Participants were asked to select one of the following options after each treatment: very much improved, much improved, slightly improved, no change, slightly worse, much worse, very much worse.
The Number of Participants With Adverse Events After Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)
Time frame · From start of infusion to end of study visit (Day 9)
Registry description
The number of participants in Part B with the following adverse events will be reported after placebo and after intravenous LAT8881 * 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (participants)
Part A, LAT8881 0.8 mg/kg	1
Part A, LAT8881 1.2 mg/kg	1
Part A, LAT8881 1.8 mg/kg	2
Part A, Placebo	2

Primary outcomeMean· From start of infusion to 6 hours after start of infusion

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

Group	Value (score on a scale)	Spread
LAT8881	3.7	2.7
Placebo	3.1	2.3

Secondary and other outcome results(6)

Secondary outcomeMean· Up to 6 hours after the start of each infusion

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

Group	Value (ng/mL)	Spread
Part A, LAT8881 0.8 mg/kg	12.6	19.1
Part A, LAT8881 1.2 mg/kg	10.2	12.9
Part A, LAT8881 1.8 mg/kg	13.8	14.1
Part A, Placebo	not posted	–

Secondary outcomeMean· Up to 6 hours after the start of each infusion

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

Group	Value (hours)	Spread
Part A, LAT8881 0.8 mg/kg	0.08	0
Part A, LAT8881 1.2 mg/kg	0.08	0
Part A, LAT8881 1.8 mg/kg	0.08	0
Part A, Placebo	not posted	–

Secondary outcomeMean· 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)

Group	Value (ng/mL*h)	Spread
Part A, LAT8881 0.8 mg/kg	NA	NA
Part A, LAT8881 1.2 mg/kg	NA	NA
Part A, LAT8881 1.8 mg/kg	NA	NA
Part A, Placebo	not posted	–

Secondary outcomeMean· Up to 6 hours after the start of each infusion

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

Group	Value (hours)	Spread
Part A, LAT8881 0.8 mg/kg	NA	NA
Part A, LAT8881 1.2 mg/kg	NA	NA
Part A, LAT8881 1.8 mg/kg	NA	NA
Part A, Placebo	not posted	–

Secondary outcomeCount of participants· 6 hours after the start of each infusion

Patient General Impression of Change (Part B)

Group	Value (Participants)
LAT8881	2
Placebo	0

Secondary outcomeNumber· From start of infusion to end of study visit (Day 9)

The Number of Participants With Adverse Events After Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)

Group	Value (participants)
LAT8881	5
Placebo	4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Part A, LAT8881 0.8 mg/kgLAT8881 was given as a single intravenous infusion at a dose of 0.8 mg/kg	0 / 6	0 / 6	1 / 6
Part A, LAT8881 1.2 mg/kgLAT8881 was given as a single intravenous infusion at a dose of 1.2 mg/kg	0 / 6	0 / 6	1 / 6
Part A, LAT8881 1.8 mg/kgLAT8881 was given as a single intravenous infusion at a dose of 1.8 mg/kg	0 / 6	0 / 6	2 / 6
Part A, PlaceboPlacebo was given as a single intravenous infusion	0 / 6	0 / 6	2 / 6
Part B, LAT8881LAT8881 was given as a single intravenous infusion at a dose of 1.8 mg/kg	0 / 17	0 / 17	5 / 17
Part B, PlaceboPlacebo was given as a single intravenous infusion	0 / 17	0 / 17	4 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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