A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.

ABSTRACT:

Aims

The peptide nangibotide is the first clinical-stage agent targeting the immunoreceptor TREM-1 (triggering receptor expressed on myeloid cells-1) and is being investigated as a novel therapy for acute inflammatory disorders such as septic shock. This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.

Methods

Twenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a single continuous intravenous infusion. The first two groups received a single i.v. dose of 1 and 10 mg, respectively, over 15 min. Subsequent groups were randomized in a product : placebo ratio of 3:1 at doses ranging from 0.03 to 6 mg kg

SUBMITTER: Cuvier V 

PROVIDER: S-EPMC6138490 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature