A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of RC-01 given either twice daily or three times daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Intravenous single escalating doses of RC-01
Intravenous single doses of placebo to match RC-01
Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
Celerion
Phoenix, Arizona, United States
Number of participants with a treatment-related adverse event collected over the duration of the study
Safety assessments will include physical examinations, vital signs including heart rate and respiratory rate, clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis), and ECG parameters (including P-wave onset, QRS onset, QRS offset, and end of T wave)
Time frame: Up to the final follow-up 1 day visit
Plasma concentration time data for RC-01 and metabolites
Individual and mean plasma concentration time data for RC-01 and its metabolites
Time frame: Pre-dose through 24 hours after the final infusion of study drug
Bioavailability of RC-01 and other RC-01 metabolites
Levels of RC-01 and metabolites in blood
Time frame: Pre-dose through 24 hours after the final infusion of study drug
Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration
Levels of RC-01 and its metabolites in the urine
Time frame: Pre-dose through 24 hours after the final infusion of study drug
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Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days