Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects

Phase 1 Completed 27 enrolled Inotrem Richmond Pharmacology Limited · collab

RandomizedParallel-groupDouble-blindOther

Summary

This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers

Timeline

Start: 2016-04-01
Primary completion: 2016-08-25
Completion: 2016-08-25

Publications

Results Cuvier V, Lorch U, Witte S, Olivier A, Gibot S, Delor I, Garaud JJ, Derive M, Salcedo-Magguilli M. A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition. Br J Clin Pharmacol. 2018 Oct;84(10):2270-2279. doi: 10.1111/bcp.13668. Epub 2018 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	nangibotide	Peptide	0.03 mg/kg	Intravenous
Subject	nangibotide	Peptide	1 mg	Intravenous
Subject	nangibotide	Peptide	6 mg/kg	Intravenous
Subject	nangibotide	Peptide	10 mg	Intravenous

Indications

No indication recorded.