Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oritavancin · 3 trials · 3 indications
a composite measure of the number and types of AEs/SAEs encountered and relationship to time of dosing
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline
A composite of multiple physical examination findings, assessing the clinical significance of any changes from baseline
Time to resolution of elevations in PT/INR, ACT, APTT, Chromogenic Factor Xa level, D-dimer, Silica Clot Time and DRVVT value will be descriptively summarized for each assay. If appropriate, two-sided 95% confidence interval for the median time will also be provided.
PK parameters (AUC)
| Arm | Type | Description |
|---|---|---|
| Oritavancin | EXPERIMENTAL | Subjects randomized to oritavancin will receive four doses (Cohort 1) or eight doses (Cohort 2) of 1200 mg oritavancin, infused intravenously over 3 hours |
| Placebo | PLACEBO_COMPARATOR | Subjects randomized to placebo will receive four doses (Cohort 1) or eight doses (Cohort 2) of 1000 mL D5W, infused intravenously over 3 hours |
| Name | Type | Description |
|---|---|---|
| Oritavancin | DRUG | - |
| Placebo (D5W) | DRUG | - |
Inclusion Criteria: 1. Subject is able to provide written informed consent before initiation of any study-related procedures. 2. Healthy male or female between the ages of 18 and 55 years, inclusive. 3. Body mass index (BMI) \< 45 kg/m\^2. 4. Subject is in good health based on medical history and p...
Current Formulation of Oritavancin is an investigational small molecule being studied for gram-positive bacterial infections, acute bacterial skin and skin structure infection (ABSSSI), and in healthy volunteers. It is in Phase 1 clinical development and is not yet approved by the FDA.
Current Formulation of Oritavancin is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics.
Current Formulation of Oritavancin is in Phase 1 clinical development. All four clinical trials listed for this drug have been completed, with a total enrollment of 102 participants. The drug remains investigational and has not received FDA approval.
Current Formulation of Oritavancin has completed four Phase 1 trials: NCT02134301 in pediatric participants with gram-positive bacterial infections, NCT02357524 in healthy volunteers in New Zealand, NCT02470702 in healthy subjects in the US, and NCT03873987 in ABSSSI patients. All trials are completed.
Current Formulation of Oritavancin is the drug being studied in the clinical trial NCT03873987, which is titled 'Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients.' This indicates that Kimyrsa is the brand name or alternative name for the formulation being tested in that trial.