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.

Study Overview

• Status: Terminated
• Conditions: Safety
• Intervention / Treatment: Drug: Single intravenous doses of RC-01; Drug: Single intravenous doses of placebo; Drug: Multiple intravenous doses of RC-01; Drug: Multiple intravenous doses of placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single intravenous doses of RC-01; Single escalating doses of RC-01 from 200 mg to 1600 mg	Drug: Single intravenous doses of RC-01; Intravenous single escalating doses of RC-01
Placebo Comparator: Single intravenous doses of placebo; Single intravenous doses of placebo to match RC-01	Drug: Single intravenous doses of placebo; Intravenous single doses of placebo to match RC-01
Active Comparator: Multiple intravenous doses of RC-01; Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined	Drug: Multiple intravenous doses of RC-01; Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
Placebo Comparator: Multiple intravenous doses of placebo; Two or three times daily intravenous doses of placebo to match RC-01	Drug: Multiple intravenous doses of placebo; Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Recida Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2019
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): May 8, 2019

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RC-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No