Single and Multiple Dose Escalation Trial of an Intravenous Antibiotic RC-01

A Phase 1, Double-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RC-01 for Injection in Healthy Adult Subjects

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.

Inclusion Criteria:

• Healthy subjects
• Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
• Willing and able to provide written informed consent

Exclusion Criteria:

• Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders
• Unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements
• Women who are pregnant and/or nursing