NCT03832517

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Recida Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	Single intravenous doses of RC-01	Intravenous single escalating doses of RC-01
DRUG	Single intravenous doses of placebo	Intravenous single doses of placebo to match RC-01
DRUG	Multiple intravenous doses of RC-01	Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
DRUG	Multiple intravenous doses of placebo	Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days

Timeline

• Start date: 2019-04-14
• Primary completion: 2019-04-22
• Completion: 2019-05-08
• First posted: 2019-02-06
• Last updated: 2019-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study