Safety
Conditions
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.
Interventions
DRUGSingle intravenous doses of RC-01
Intravenous single escalating doses of RC-01
Intravenous single doses of placebo to match RC-01
DRUGMultiple intravenous doses of RC-01
Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days
Sponsors
Recida Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed