biostudies-literatureCuvier VAgence Nationale de la Recherche2270-2279https://www.ebi.ac.uk/biostudies/studies/S-EPMC6138490biostudies-literatureUnknown84(10)<h4>Aims</h4>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.<h4>Methods</h4>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<supBritish journal of clinical pharmacologyA first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.PMC6138490ANR-15-RHU-0004Delor ILorch UCuvier VSalcedo-Magguilli MOlivier AWitte SGibot SDerive MGaraud JJfalseA first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.<h4>Aims</h4>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.<h4>Methods</h4>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<sup2018-01-01T00:00:00Z2018 Oct2025-04-22T06:46:08.106Z2019-10-11T07:16:07ZS-EPMC61384902988506810.1111/bcp.13668