Safety, tolerability and pharmacokinetics of subcutaneous and intravenous anifrolumab in healthy volunteers.

ABSTRACT:

Objectives

To compare the pharmacokinetics (PK), safety and tolerability of subcutaneous (SC) and intravenous anifrolumab, an anti-type I interferon receptor monoclonal antibody in development for SLE, in healthy volunteers.

Methods

In this Phase I randomised, placebo-controlled study, 30 adults were assigned to three treatment cohorts (anifrolumab 300 mg SC (n=6), anifrolumab 300 mg intravenous (n=6), anifrolumab 600 mg SC (n=6)) and placebo (n=4/cohort). Serial blood samples were collected up to Day 84 to measure anifrolumab concentrations and antidrug antibodies (ADAs). PK parameters were estimated by noncompartmental analysis.

Results

Maximum serum concentrations in SC cohorts occurred after 4-7 days. Anifrolumab serum concentrations were below the limit of detect

SUBMITTER: Tummala R 

PROVIDER: S-EPMC5890854 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature