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

• ClinicalTrials.gov Identifier: NCT03832517
• Recruitment Status: Terminated
• First Posted: February 6, 2019
• Last Update Posted: May 29, 2019
• Sponsor: Recida Therapeutics, Inc.
• Information provided by (Responsible Party): Recida Therapeutics, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Safety	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	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 14, 2019
• Actual Primary Completion Date: April 22, 2019
• Actual Study Completion Date: May 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of participants with a treatment-related adverse event collected over the duration of the study [ Time Frame: Up to the final follow-up 1 day visit ]
   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)

Secondary Outcome Measures :

1. Plasma concentration time data for RC-01 and metabolites [ Time Frame: Pre-dose through 24 hours after the final infusion of study drug ]
   Individual and mean plasma concentration time data for RC-01 and its metabolites
2. Bioavailability of RC-01 and other RC-01 metabolites [ Time Frame: Pre-dose through 24 hours after the final infusion of study drug ]
   Levels of RC-01 and metabolites in blood
3. Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration [ Time Frame: Pre-dose through 24 hours after the final infusion of study drug ]
   Levels of RC-01 and its metabolites in the urine

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Celerion

Phoenix, Arizona, United States, 85283

Sponsors and Collaborators

Recida Therapeutics, Inc.

More Information

• Responsible Party: Recida Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03832517
• Other Study ID Numbers: RC-01-001
• First Posted: February 6, 2019
• Last Update Posted: May 29, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No