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Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults With Bacteremia Due to Staphylococcus Aureus
Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to Best Available Antibiotic Therapy Alone for the Treatment of Adults With Bacteremia Due to Staphylococcus aureus
This study will be conducted in two phases: Phase 1b will to evaluate the safety and tolerability of multiple ascending intravenous (IV) doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteremia (SAB). Phase 2a will evaluate the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner University Medical Center
Tucson, Arizona, United States
University of California, San Diego (UCSD) - Medical Center
La Jolla, California, United States
University of Southern California Keck School of Medicine
Los Angeles, California, United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
University of Florida (UF) - Division of Infectious Disease
Gainesville, Florida, United States
University of Florida - Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Start Date
April 26, 2022
Primary Completion Date
November 7, 2024
Completion Date
January 14, 2025
Last Updated
October 3, 2025
50
ACTUAL participants
AP-SA02
BIOLOGICAL
Placebo
OTHER
Lead Sponsor
Armata Pharmaceuticals, Inc.
Collaborators
NCT06650501
NCT06749457
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07299539