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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Safety

In brief

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.

Key facts

Study ID

NCT03832517

Run by

Recida Therapeutics, Inc.

People needed

8

Starts

2019-04-14

Expected to finish

2019-05-08

Last updated by the study team

2019-05-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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