A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

Phase 1 Completed 24 enrolled Neurop Inc. National Institute of Neurological Disorders and Stroke (NINDS) · collab Pharmaron · collab

RandomizedSequentialQuadruple-blindTreatment

Summary

This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Timeline

Start: 2019-04-04
Primary completion: 2019-08-30
Completion: 2019-10-10

Publications

Zaczek R, Traynelis SF, Dingledine R, Koszalka GW, Laskowitz DT. Phase 1 Clinical Results for NP10679, a pH-sensitive GluN2B-selective N-methyl-d-aspartate Receptor Inhibitor. Clin Pharmacol Drug Dev. 2023 Jul;12(7):706-717. doi: 10.1002/cpdd.1217. Epub 2023 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NP10679	Small molecule	25 mg	Intravenous
Subject	NP10679	Small molecule	50 mg	Intravenous
Subject	NP10679	Small molecule	100 mg	Intravenous

A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

Summary

Timeline

Publications

Drugs

Indications