Loading clinical trials...

COMPLETEDPHASE1

Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease

A Phase 1b, Open-Label, Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease

NCT03487263•Implicit Bioscience

Summary

Ten patients with motor neurone disease (MND, also known as amyotrophic lateral sclerosis or ALS) will be successively enrolled to one of two dose levels of IC14 (human chimeric monoclonal anti-CD14) intravenously for four doses. Patients must be within 3 years of MND diagnosis and have adequate respiratory function. Safety, tolerability, immunogenicity, and PK/PD will be measured. To evaluate feasibility of the endpoints, additional endpoints of ALSFRS-R, respiratory function tests, disease biomarkers and patient-reported outcomes will be measured.

Detailed Description

The objectives of this study are to determine: * The safety, tolerability and immunogenicity of IC14 in patients with motor neurone disease (MND). * The pharmacokinetics and pharmacodynamics of IC14 in patients with MND. * The preliminary effect of IC14 on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) in patients with MND. * The preliminary effect of IC14 on forced vital capacity (FVC) and other clinical markers of disease severity in patients with MND. * The preliminary effect of IC14 on patient-reported outcome measures. * The preliminary effect of IC14 on disease biomarkers. Ten patients with MND will be sequentially assigned to receive one of two dose regimens of IC14 in an unblinded manner: * For the initial 3 patients: IC14 at a dosage of 2 mg/kg on Study Day 1, then 1 mg/kg once daily on Study Days 3-5 for 4 total doses. * For the subsequent 7 patients: IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 for 4 total doses. Study participation will continue until 28 days after the last dose of study drug.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A patient must fulfill all of the following criteria to be eligible for enrollment:
•1. Signed informed consent prior to initiation of any study-specific procedures.
•2. Familial or sporadic motor neurone disease (MND) defined as clinically possible, probable, or definite by Awaji-Shima Consensus Recommendations.
•3. First symptoms of MND within 3 years of informed consent.
•4. Age between 18 and 75 years at time of informed consent.
•5. Seated Forced Vital Capacity (FVC) ≥ 65% of predicted value.
•6. Not taking riluzole or on a stable dose of riluzole for at least 4 weeks prior to screening visit.
•7. Adequate bone marrow reserve, renal and liver function:
•* absolute neutrophil count ≥ 1500/µL
•* lymphocyte count \< 48%
+14 more criteria

Exclusion Criteria

•A patient fulfilling any of the following criteria at screening is to be excluded from enrollment in the study:
•1. Dependence on mechanical ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening; or presence of diaphragm pacing system at screening.
•2. Treatment with a drug or device within the last 30 days that has not received regulatory approval.
•3. Treatment within 12 months with immunomodulator or immunosuppressant agent (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β-1a, rituximab, alemtuzumab, azathioprine, etanercept, infliximab, adalimumab, certolizumab, golimumab, anakinra, rilonacept, secukinumab, tocilizumab, mycophenolate mofetil, methotrexate, haematopoietic stem cell transplantation).
•4. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections or major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks.
•5. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
•6. Presence of any of the following clinical conditions:
•* Bleeding diathesis or receipt of anticoagulants within 7 days (or any other clinical condition that would, in the opinion of the investigator, place the patient at increased risk during lumbar puncture).
•* History of one or more of the following: cardiac insufficiency (New York Heart Association \[NYHA\] III/IV), uncontrolled cardiac arrhythmias, unstable ischemic heart disease, or uncontrolled hypertension (systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 110 mmHg).
•* History of venous thromboembolic disease within 12 months, myocardial infarction, or cerebrovascular accident.
+10 more criteria

Locations (1)

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Key Dates

Start Date

October 1, 2017

Primary Completion Date

April 18, 2018

Completion Date

December 30, 2018

Last Updated

August 20, 2025

Enrollment

ACTUAL participants

Conditions

Motor Neuron DiseaseAmyotrophic Lateral Sclerosis

Interventions

IC14

BIOLOGICAL

Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)

NCT04944940

Spinal and Bulbar Muscular AtrophyKennedys Disease+1 more

View study

RECRUITINGPHASE3

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Amyotrophic Lateral Sclerosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease

Inclusion Criteria

Exclusion Criteria

Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

UPenn Observational Research Repository on Neurodegenerative Disease

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

Control Cohort CTRL COH