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

NCT03487263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

IC14

chimeric monoclonal antibody against human IC14

Sponsors & Collaborators

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • Implicit Bioscience

    lead INDUSTRY

Principal Investigators

  • Robert D. Henderson, MBBS · Royal Brisbane and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-04-18
Completion
2018-12-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03487263 on ClinicalTrials.gov