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

Study Overview
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Brief Summary
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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.

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

Conditions
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Safety

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |