A Study to Investigate Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Healthy Volunteers

Phase 1 Completed 30 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers, enrolled at a single site in the United States to investigate the safety, tolerability, and pharmacokinetics of DSTA4637S.

Timeline

Start: 2015-11-29
Primary completion: 2016-05-30
Completion: 2016-05-30

Publications

Peck M, Rothenberg ME, Deng R, Lewin-Koh N, She G, Kamath AV, Carrasco-Triguero M, Saad O, Castro A, Teufel L, Dickerson DS, Leonardelli M, Tavel JA. A Phase 1, Randomized, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S, an Anti-Staphylococcus aureus Thiomab Antibody-Antibiotic Conjugate, in Healthy Volunteers. Antimicrob Agents Chemother. 2019 May 24;63(6):e02588-18. doi: 10.1128/AAC.02588-18. Print 2019 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DSTA4637S	Unknown	5 mg/kg	Intravenous
Subject	DSTA4637S	Unknown	15 mg/kg	Intravenous
Subject	DSTA4637S	Unknown	50 mg/kg	Intravenous
Subject	DSTA4637S	Unknown	100 mg/kg	Intravenous
Subject	DSTA4637S	Unknown	150 mg/kg	Intravenous

Indications

No indication recorded.