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TD-1607, administered intravenously as single doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Single escalating doses of TD-1607, administered intravenously |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1607 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Adverse events, laboratory abnormalities, ECGs, and vital sign measurements. | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Cmax, Tmax, AUC0-t, AUC0-24, AUCinf, CL, Vdss, t1/2, amount excreted in urine (Ae), fraction eliminated in urine (fe), and CLr. | 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase 1 | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
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