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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03832517
• Other study ID #: RC-01-001
• Status: Terminated
• Phase: Phase 1
• Start date: April 14, 2019
• Est. completion date: May 8, 2019

Study information

• Verified date: May 2019
• Source: Recida Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 8, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety

Intervention

Drug:
• Single intravenous doses of RC-01
Intravenous single escalating doses of RC-01
• Single intravenous doses of placebo
Intravenous single doses of placebo to match RC-01
• Multiple intravenous doses of RC-01
Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
• Multiple intravenous doses of placebo
Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days

Locations

Country	Name	City	State
United States	Celerion	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Recida Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to the final follow-up 1 day visit
Secondary	Plasma concentration time data for RC-01 and metabolites	Individual and mean plasma concentration time data for RC-01 and its metabolites	Pre-dose through 24 hours after the final infusion of study drug
Secondary	Bioavailability of RC-01 and other RC-01 metabolites	Levels of RC-01 and metabolites in blood	Pre-dose through 24 hours after the final infusion of study drug
Secondary	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	Pre-dose through 24 hours after the final infusion of study drug