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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05298306




Registration number
NCT05298306
Ethics application status
Date submitted
3/03/2022
Date registered
28/03/2022

Titles & IDs
Public title
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
Scientific title
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
Secondary ID [1] 0 0
LAT-NP-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiculopathy Lumbar 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LAT8881
Treatment: Drugs - Placebo

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


Treatment: Drugs: LAT8881
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

Treatment: Drugs: Placebo
Matching placebo'given as a single intravenous infusion at all dose levels
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants With Adverse Events by Dose (Part A)
Timepoint [1] 0 0
From first dose of LAT8881 to end of study visit (Day 14)
Primary outcome [2] 0 0
Change in Baseline Pain With Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)
Timepoint [2] 0 0
From start of infusion to 6 hours after start of infusion
Secondary outcome [1] 0 0
Maximum Plasma LAT8881 Concentration (Cmax) After Intravenous LAT8881 (Part A)
Timepoint [1] 0 0
Up to 6 hours after the start of each infusion
Secondary outcome [2] 0 0
Time to Maximum Plasma LAT8881 Concentration (Tmax) After Intravenous LAT8881 (Part A)
Timepoint [2] 0 0
Up to 6 hours after the start of each infusion
Secondary outcome [3] 0 0
Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) After Intravenous LAT8881 (Part A)
Timepoint [3] 0 0
Up to 6 hours after the start of each infusion
Secondary outcome [4] 0 0
Terminal Elimination Half Life (T1/2), (Part A)
Timepoint [4] 0 0
Up to 6 hours after the start of each infusion
Secondary outcome [5] 0 0
Patient General Impression of Change (Part B)
Timepoint [5] 0 0
6 hours after the start of each infusion
Secondary outcome [6] 0 0
The Number of Participants With Adverse Events After Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)
Timepoint [6] 0 0
From start of infusion to end of study visit (Day 9)

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/06/2023
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
PARC Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lateral Pharma Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Southern Star Research Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Guy Ludbrook, MBBS
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05298306