A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers

Phase 1 Completed 94 enrolled Spero Therapeutics Clinical Network Services (CNS) Pty Ltd · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of SPR206 when administered to healthy adult volunteers.

Timeline

Start: 2018-12-18
Primary completion: 2019-12-23
Completion: 2019-12-23

Publications

Bruss J, Lister T, Gupta VK, Stone E, Morelli L, Lei Y, Melnick D. Single- and Multiple-Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics of the Polymyxin Derivative SPR206. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0073921. doi: 10.1128/AAC.00739-21. Epub 2021 Aug 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	UPLEGANAN	Other / unclassified	10 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	25 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	50 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	100 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	150 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	200 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	250 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	300 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	350 mg	Intravenous
Subject	UPLEGANAN	Other / unclassified	400 mg	Intravenous

Indications

No indication recorded.