A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants

Phase 1 Completed 36 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

Summary

Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for the treatment of Alzheimer's Disease.

Timeline

Start: 2019-08-03
Primary completion: 2020-07-17
Completion: 2020-07-17

Publications

Muliaditan M, van Steeg TJ, Avery LB, Sun W, Hammond TR, Hijdra D, Choi SL, Pillai N, Leksa NC, Mavroudis PD. Translational minimal physiologically based pharmacokinetic model for transferrin receptor-mediated brain delivery of antibodies. MAbs. 2025 Dec;17(1):2515414. doi: 10.1080/19420862.2025.2515414. Epub 2025 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trontinemab	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	Trontinemab	Monoclonal antibody	0.4 mg/kg	Intravenous
Subject	Trontinemab	Monoclonal antibody	1.2 mg/kg	Intravenous
Subject	Trontinemab	Monoclonal antibody	3.6 mg/kg	Intravenous
Subject	Trontinemab	Monoclonal antibody	7.2 mg/kg	Intravenous

A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants

Summary

Timeline

Publications

Drugs

Indications