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

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.

Timeline

Start

2017-10-01

Primary completion

2018-04-18

Completion

2018-12-30

Publications

• Results Henderson RD, Agosti JM, McCombe PA, Thorpe K, Heggie S, Heshmat S, Appleby MW, Ziegelaar BW, Crowe DT, Redlich GL. Phase 1b dose-escalation, safety, and pharmacokinetic study of IC14, a monoclonal antibody against CD14, for the treatment of amyotrophic lateral sclerosis. Medicine (Baltimore). 2021 Oct 22;100(42):e27421. doi: 10.1097/MD.0000000000027421.

Drugs

Indications