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safety
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single intravenous doses of RC-01 | Active Comparator | Single escalating doses of RC-01 from 200 mg to 1600 mg |
|
| Single intravenous doses of placebo | Placebo Comparator | Single intravenous doses of placebo to match RC-01 |
|
| Multiple intravenous doses of RC-01 | Active Comparator | Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined |
|
| Multiple intravenous doses of placebo | Placebo Comparator | Two or three times daily intravenous doses of placebo to match RC-01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single intravenous doses of RC-01 | Drug | Intravenous single escalating doses of RC-01 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Phoenix | Arizona | 85283 | United States |
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| Single intravenous doses of placebo | Drug | Intravenous single doses of placebo to match RC-01 |
|
| Multiple intravenous doses of RC-01 | Drug | Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days |
|
| Multiple intravenous doses of placebo | Drug | Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days |
|
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 |