Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-1607 · 2 trials · 3 indications
Adverse events
Adverse events, laboratory abnormalities, ECGs, and vital sign measurements.
| Arm | Type | Description |
|---|---|---|
| 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 | TD-1607 or placebo administered intravenously |
| Active | EXPERIMENTAL | Single escalating doses of TD-1607, administered intravenously |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| TD-1607 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening. * Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg. Subject has no clinically significant abnormalities...
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TD-1607 is an investigational small molecule being developed for serious infections due to known or suspected Gram-positive pathogens, as well as for bacterial infections. It is currently in Phase 1 clinical development and has not been approved by the FDA.
TD-1607 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TBPH. The company is conducting clinical trials for this investigational drug in the United States.
TD-1607 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a single ascending dose study and a multiple ascending dose study in healthy subjects. The drug remains investigational and is not yet approved.
TD-1607 has been studied in two completed Phase 1 clinical trials: NCT01791049, a single ascending dose study in healthy subjects with 64 participants, and NCT01949103, a multiple ascending dose study in healthy subjects with 48 participants. Both trials were conducted in the United States.
TD-1607 is the primary name for this investigational drug. No alternative names have been associated with it in the available clinical trial data. It is a small molecule being developed by Theravance Biopharma for Gram-positive infections.