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

Phase 1 Completed 10 enrolled Implicit Bioscience Royal Brisbane and Women's Hospital · collab

Non-randomizedSequentialOpen-labelTreatment

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

Outcome

Met primary endpoint

paper This study demonstrated safety and tolerability in patients with amyotrophic lateral sclerosis. PMID 34678870 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	IC14	Monoclonal antibody	1 mg/kg	Intravenous
Subject	IC14	Monoclonal antibody	2 mg/kg	Intravenous