Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Phase 1b, Open-Label, Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease
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.
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.
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