Clinical Trials Directory

Trials / Completed

CompletedNCT05184764

Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Armata Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAP-SA02Bacteriophage administered via intravenous bolus infusion
OTHERPlaceboInactive Placebo administered via intravenous bolus infusion

Timeline

Start date
2022-04-26
Primary completion
2024-11-07
Completion
2025-01-14
First posted
2022-01-11
Last updated
2026-03-23
Results posted
2026-03-23

Locations

28 sites across 2 countries: United States, Australia

Regulatory

Source: ClinicalTrials.gov record NCT05184764. Inclusion in this directory is not an endorsement.