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TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-1607 or placebo (Dose1) | Experimental | TD-1607 or placebo administered intravenously |
|
| TD-1607 or placebo (Dose 2) | Experimental | TD-1607 or placebo administered intravenously |
|
| TD-1607 or placebo (Dose 3) | Experimental | TD-1607 or placebo administered intravenously |
|
| TD-1607 or placebo (Dose 4) | Experimental | TD-1607 or placebo administered intravenously |
|
| TD-1607 or placebo (Dose 5) [Optional] | Experimental | TD-1607 or placebo administered intravenously |
|
| TD-1607 or placebo (Dose 6) [Optional] | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-1607 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Adverse events | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics | 17 Days |
| Tmax | Pharmacokinetics | 17 Days |
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Inclusion Criteria:
Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.
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 Clinic | 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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TD-1607 or placebo administered intravenously
|
| Placebo | Drug |
|
| AUC0-t |
Pharmacokinetics |
| 17 Days |
| AUC0-24 | Pharmacokinetics | 17 Days |
| AUCinf | Pharmacokinetics | 17 Days |
| CL | Pharmacokinetics | 17 Days |
| Vdss | Pharmacokinetics | 17 Days |
| t1/2 | Pharmacokinetics | 17 Days |
| Amount excreted in urine (Ae | Pharmacokinetics | 17 Days |
| Fraction eliminated in urine (fe) | Pharmacokinetics | 17 Days |
| CLr | Pharmacokinetics | 17 Days |
| Ctrough | Pharmacokinetics | 17 Days |