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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
DSTA4637S will be administered as an IV infusion at 3 dose levels.
Placebo matched to DSTA4637S IV infusion will be administered as specified.
Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance, California, United States
Henry Ford Health System
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Chungnam National University Hospital
Daejeon, South Korea
Gyeongsang National University Hospital
Gyeongsangnam-do, South Korea
Asan Medical Center - Oncology
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
...and 6 more locations
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to approximately 156 Days
Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma
Time frame: Baseline up to approximately 156 Days
Measure of DSTA4637S Total Antibody measured by Serum
Time frame: Baseline up to approximately 156 Days
Measure of Unconjugated dmDNA31 measured by Plasma
Time frame: Baseline up to approximately 156 Days
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S
Time frame: Baseline up to approximately 156 Days
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