Radiculopathy LumbarPhase 1NCT05298306

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

A Phase 1 study testing LAT8881 in people with Radiculopathy Lumbar, run by Lateral Pharma Pty Ltd at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Radiculopathy Lumbar
What is being tested?: LAT8881
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteAustralia
Study dates: 17 May 2022to 16 Jun 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

Show all 16Show fewer

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

PARC Clinical Research
Adelaide, South Australia, 5000

Other trials in Australia

About this study

Healthy volunteers are not accepted for Part B.

Read the 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 three treatment days, 1 infusion per dosing day, on Days 1, 4 and 7 as well as two short visits for safety blood sampling on Days 3 and 6. Subjects in Part A are randomized to receive placebo and LAT8881 according to the following treatment sequences. Two subjects are allocated to each treatment sequence, a total of eight subjects overall.

0.8 mg/kg/1.2 mg/kg/1.8 mg/kg;

0.8 mg/kg/1.2 mg/kg/Placebo;

0.8 mg/kg/Placebo/1.8 mg/kg;

Placebo/1.2 mg/kg/1.8 mg/kg.

Part B of this study is is a placebo-controlled randomized double blind cross-over safety and efficacy study of LAT8881 in up to 20 patients with lumbar radicular pain. Participants will be randomly assigned to one of two groups, to receive either LAT8881 then placebo or placebo then LAT8881. Participants will receive either a single dose of LAT8881 [the Maximum Tolerated Dose from Part A of the study] or placebo via intravenous administration over 5 minutes on two consecutive days.

Conditions: Radiculopathy Lumbar
Being tested: LAT8881, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LAT8881Drug
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
PlaceboDrug
Matching placebo'given as a single intravenous infusion at all dose levels

Study groups in NCT05298306
Study group	Role	What they receive
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. Receives: Drug: LAT8881
Placebo	Placebo comparator	Matching placebo will be given as a single intravenous infusion in Part A and Part B Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: From start of infusion to 6 hours after start of infusion

Secondary outcomes (6)

Maximum Plasma LAT8881 Concentration (Cmax) After Intravenous LAT8881 (Part A)
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
Measured: Up to 6 hours after the start of each infusion
Time to Maximum Plasma LAT8881 Concentration (Tmax) After Intravenous LAT8881 (Part A)
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
Measured: 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)
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.
Measured: Up to 6 hours after the start of each infusion
Terminal Elimination Half Life (T1/2), (Part A)
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.
Measured: Up to 6 hours after the start of each infusion
Patient General Impression of Change (Part B)
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.
Measured: 6 hours after the start of each infusion
The Number of Participants With Adverse Events After Intravenous LAT8881 in Patients With Lumbar Radicular Pain (Part B)
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
Measured: From start of infusion to end of study visit (Day 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 202216 Jun 2023

First posted28 Mar 2022
Study start17 May 2022
Primary completion12 May 2023
Study completion16 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Radiculopathy LumbarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: The crossover study (Part B) is preceded by a single ascending dose study (Part A)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05298306
Sponsor's protocol ID: LAT-NP-002
Status last verified: Nov 2024
First submitted: 3 Mar 2022
Last updated: 27 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Tecar Therapy in Patients With Lumbar Radiculopathy
Lumbar Radiculopathy

All Radiculopathy Lumbar trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
ClinicalTrials.gov ID: NCT05298306
Acronym / sponsor ID: LAT-NP-002
Conditions: Radiculopathy Lumbar
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Lateral Pharma Pty LtdIndustry (pharma, biotech, devices)
Collaborators: Southern Star Research
Study start: 17 May 2022 (actual)
Primary completion: 12 May 2023 (actual)
Study completion: 16 Jun 2023 (actual)
First posted: 28 Mar 2022 (actual)
Results: Posted 27 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Healthy volunteers are not accepted for Part B.

Detailed description

0.8 mg/kg/1.2 mg/kg/1.8 mg/kg;

0.8 mg/kg/1.2 mg/kg/Placebo;

0.8 mg/kg/Placebo/1.8 mg/kg;

Placebo/1.2 mg/kg/1.8 mg/kg.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: The crossover study (Part B) is preceded by a single ascending dose study (Part A)

Arm	Type	Receives
LAT8881	Experimental	Drug: LAT8881In 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	Placebo comparator	Drug: PlaceboMatching placebo will be given as a single intravenous infusion in Part A and Part B

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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;

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LAT8881In 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	Drug	LAT8881
PlaceboMatching placebo'given as a single intravenous infusion at all dose levels	Drug	Placebo

Primary outcome

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)
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
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

6 secondary outcomes

Maximum Plasma LAT8881 Concentration (Cmax) After Intravenous LAT8881 (Part A)
Time frame: Up to 6 hours after the start of each infusion
Time to Maximum Plasma LAT8881 Concentration (Tmax) After Intravenous LAT8881 (Part A)
Time frame: 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)
Time frame: Up to 6 hours after the start of each infusion
Terminal Elimination Half Life (T1/2), (Part A)
Time frame: Up to 6 hours after the start of each infusion
Patient General Impression of Change (Part B)
Time frame: 6 hours after the start of each infusion
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)

Results and safety

Results posted to the registry on 27 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A (0.8 mg/kg; 1.2 mg/kg; 1.8 mg/kg)	2	2
Part A (0.8 mg/kg; 1.2 mg/kg; Placebo)	2	2
Part A (0.8 mg/kg; Placebo; 1.8 mg/kg)	2	2
Part A (Placebo; 1.2 mg/kg; 1.8 mg/kg)	3	2
Part B, LAT8881/Placebo	8	8
Part B Placebo/LAT8881	9	9

Primary outcome: 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). Number. Unit: participants

Measure	Part A, LAT8881 0.8 mg/kg n = 6	Part A, LAT8881 1.2 mg/kg n = 6	Part A, LAT8881 1.8 mg/kg n = 6	Part A, Placebo n = 6
Any adverse event	1	1	2	2
Serious adverse event	0	0	0	0
Adverse events leading to premature discontinuation of Investigational Medicinal Product (IMP)	0	0	0	0
Adverse event of Grade 3 or 4 severity	0	0	0	0
Adverse events related to IMP (possibly, probably or definitely)	0	0	2	1

Population analysed: Safety population. This population included all subjects who received at least one dose of IMP and had at least one post dose safety assessment.

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	LAT8881 n = 17	Placebo n = 17
Pre-dose VAS score	3.7 (2.7)	3.1 (2.3)
Change from pre-dose score at 0.25 hours	-0.8 (1.8)	-0.3 (1.1)
Change from pre-dose score at 0.5 hours	-0.8 (2.0)	-0.3 (1.5)
Change from pre-dose score at 0.75 hours	-1.0 (1.8)	-0.5 (1.5)
Change from pre-dose score at 1.0 hours	-1.1 (2.2)	-0.6 (1.4)
Change from pre-dose score at 1.5 hours	-0.8 (1.8)	-0.5 (1.1)
Change from pre-dose score at 2 hours	-0.8 (2.0)	-0.4 (1.4)
Change from pre-dose score at 2.5 hours	-0.8 (2.1)	-0.6 (1.4)

LAT8881 vs Placebo: Mean Difference (Net): -0.25 (95% CI -1.02 to 0.52), p = 0.5196, Mixed Models Analysis
LAT8881 vs Placebo: Mean Difference (Net): -0.32 (95% CI -1.09 to 0.44), p = 0.3983, Mixed Models Analysis
LAT8881 vs Placebo: Mean Difference (Net): -0.26 (95% CI -1.03 to 0.5), p = 0.4890, Mixed Models Analysis

Population analysed: Full Analysis Set. This population included all enrolled and randomised participants.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All events occurring during and following the first administration of IMP were reported as adverse events until the completion of the End of Study Evaluation visit (Day 14 for Part A, Day 9 for Part B).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A, LAT8881 0.8 mg/kg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A, LAT8881 1.2 mg/kg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A, LAT8881 1.8 mg/kg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A, Placebo	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part B, LAT8881	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
Part B, Placebo	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Radiculopathy Lumbar

Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Tecar Therapy in Patients With Lumbar Radiculopathy
Lumbar Radiculopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guy Ludbrook, MBBS principal investigator

Royal Adelaide Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LAT8881 in people with Radiculopathy Lumbar, run by Lateral Pharma Pty Ltd at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05298306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.