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

Phase 1

Terminated

• Conditions: Safety
• Interventions: Drug: Single intravenous doses of RC-01; Drug: Multiple intravenous doses of RC-01; Drug: Multiple intravenous doses of placebo; Drug: Single intravenous doses of placebo

• Registration Number: NCT03832517
• Lead Sponsor: Recida Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Study Start: 2019-04-14
• Primary Completion: 2019-04-22
• Status Verified: 2019-05
• Study Completion: 2019-05-08
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single intravenous doses of RC-01	Single intravenous doses of RC-01	Single escalating doses of RC-01 from 200 mg to 1600 mg
Multiple intravenous doses of RC-01	Multiple intravenous doses of RC-01	Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined
Multiple intravenous doses of placebo	Multiple intravenous doses of placebo	Two or three times daily intravenous doses of placebo to match RC-01
Single intravenous doses of placebo	Single intravenous doses of placebo	Single intravenous doses of placebo to match RC-01

Primary Outcome Measures

Name	Time	Method
Number of participants with a treatment-related adverse event collected over the duration of the study	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

Name	Time	Method
Plasma concentration time data for RC-01 and metabolites	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
Bioavailability of RC-01 and other RC-01 metabolites	Pre-dose through 24 hours after the final infusion of study drug	Levels of RC-01 and metabolites in blood
Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration	Pre-dose through 24 hours after the final infusion of study drug	Levels of RC-01 and its metabolites in the urine

Trial Locations

Locations (1)

Celerion; 🇺🇸 Phoenix, Arizona, United States