NCT03162250

Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics

A Phase IB, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Patients With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care Antibiotics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S when given in addition to anti-staphylococcal SOC antibiotics to participants with methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.

Conditions

• Bacteremia

Interventions

Type	Name	Description
DRUG	DSTA4637S	DSTA4637S will be administered as an IV infusion at 3 dose levels.
DRUG	Placebo	Placebo matched to DSTA4637S IV infusion will be administered as specified.
DRUG	SOC	Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.

Timeline

• Start date: 2017-07-13
• Primary completion: 2020-01-15
• Completion: 2020-01-15
• First posted: 2017-05-22
• Last updated: 2020-01-22

Locations

16 sites across 3 countries: United States, South Korea, Spain

Regulatory

• FDA-regulated drug study