A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers

Phase 1 Completed 96 enrolled Spero Therapeutics Simbec Research · collab

RandomizedSequentialQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) following single and multiple ascending dose administration of SPR720 administered orally in healthy volunteers.

Timeline

Start: 2018-12-18
Primary completion: 2019-09-24
Completion: 2019-09-24

Publications

Talley AK, Thurston A, Moore G, Gupta VK, Satterfield M, Manyak E, Stokes S, Dane A, Melnick D. First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of SPR720, a Novel Oral Bacterial DNA Gyrase (GyrB) Inhibitor for Mycobacterial Infections. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0120821. doi: 10.1128/AAC.01208-21. Epub 2021 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SPR720	Small molecule	100 mg	Oral
Subject	SPR720	Small molecule	250 mg	Oral
Subject	SPR720	Small molecule	500 mg	Oral
Subject	SPR720	Small molecule	1000 mg	Oral
Subject	SPR720	Small molecule	1500 mg	Oral
Subject	SPR720	Small molecule	3000 mg	Oral

Indications

No indication recorded.