TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.
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Incidence of Abnormal Physical Examination Findings
Timeframe: 16 weeks
Incidence of Abnormal Serum Chemistries and Hematology
Timeframe: 16 weeks
Incidence of Abnormal Vital Signs (Temperature)
Timeframe: 16 weeks
Incidence of Abnormal Vital Signs (Blood Pressure)
Timeframe: 16 weeks
Incidence of Abnormal Vital Signs (Heart Rate)
Timeframe: 16 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 24 weeks