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This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nafithromycin | Experimental | Subjects in Cohorts 1 through 5 receive active treatments. Subjects in Cohort 6 will receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin on Day 1 |
|
| Placebo | Placebo Comparator | Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nafithromycin | Drug | 100, 200, or 400 mg of nafithromycin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve | 72 hours from dosing | |
| Maximum observed plasma concentration (Cmax) | 72 hours from dosing | |
| Time to Cmax (Tmax) | 72 hours from dosing |
| Measure | Description | Time Frame |
|---|---|---|
| clinical laboratory- Number of subjects with deranged heamatology parameters test results | 14 days | |
| 12-lead safety ECG results | 14 days | |
| Number of subjects reported with any local tolerability at the injection site assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase 1 unit : Spaulding Clinical Research, LLC | West Bend | Wisconsin | 53095 | United States |
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| ID | Term |
|---|---|
| C000627038 | nafithromycin |
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| Placebo |
| Drug |
IV matching placebo |
|
|
| 14 days |
| Number of subjects with any abonormal physical examination findings | 14 days |
| Total number of reported AEs | 14 days |