A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers

Phase 1 Completed 64 enrolled Spero Therapeutics CPR Pharma Services Pty Ltd, Australia · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and tolerability of single and multiple intravenous doses of SPR741 when administered to healthy adult volunteers.

Timeline

Start: 2016-12
Primary completion: 2017-07
Completion: 2017-09

Publications

Eckburg PB, Lister T, Walpole S, Keutzer T, Utley L, Tomayko J, Kopp E, Farinola N, Coleman S. Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741, an Intravenous Potentiator, after Single and Multiple Ascending Doses and When Combined with beta-Lactam Antibiotics in Healthy Subjects. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00892-19. doi: 10.1128/AAC.00892-19. Print 2019 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SPR741	Protein / enzyme biologic	5 mg	Intravenous
Subject	SPR741	Protein / enzyme biologic	15 mg	Intravenous
Subject	SPR741	Protein / enzyme biologic	50 mg	Intravenous
Subject	SPR741	Protein / enzyme biologic	100 mg	Intravenous
Subject	SPR741	Protein / enzyme biologic	200 mg	Intravenous
Subject	SPR741	Protein / enzyme biologic	400 mg	Intravenous
Subject	SPR741	Protein / enzyme biologic	600 mg	Intravenous
Subject	SPR741	Protein / enzyme biologic	800 mg	Intravenous

Indications

No indication recorded.