Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinartis, LLC | UNKNOWN |
| Keystone Bioanalytical, Inc. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nafithromycin 200 mg as IV infusion | Experimental | Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. |
|
| placebo administered as IV infusion | Placebo Comparator | Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nafithromycin | Drug | Nafithromycin 200 mg as IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety | By measuring treatment emergent AEs | Day 19 |
| To assess multiple dose drug tolerability | By measuring treatment emergent AEs | Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess plasma PK parameters profile | Area under the plasma concentration-time curve (AUC) | Day 3 |
| To assess plasma PK parameters profile | Maximum observed plasma concentration (Cmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos Sanabria, MD | Spaulding Clinical Research LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |
Not provided
| ID | Term |
|---|---|
| C000627038 | nafithromycin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
placebo administered as IV infusion |
|
| Day 3 |
| To assess plasma PK parameters profile | Time to Cmax (Tmax) | Day 3 |
| To assess plasma PK parameters profile | Terminal half-life (t1/2) | Day 3 |