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TD-1473 for SAD · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TD-1473 for SAD | EXPERIMENTAL | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
| Placebo for SAD | PLACEBO_COMPARATOR | 2 of out 8 subjects per cohort will be randomized to receive placebo |
| TD-1473 for MAD | EXPERIMENTAL | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
| Placebo for MAD | PLACEBO_COMPARATOR | 2 of out 8 subjects per cohort will be randomized to receive placebo |
| Name | Type | Description |
|---|---|---|
| TD-1473 for SAD | DRUG | SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. |
| Placebo for SAD | DRUG | SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. |
| TD-1473 for MAD | DRUG | MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. |
| Placebo for MAD | DRUG | MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. |
Inclusion Criteria: * Healthy male or female 19 to 55 years old * Willing and able to give informed consent * Body Mass Index (BMI) 18 to 30 kg/m2 * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control * A...
TD-1473 is an investigational small molecule developed by Theravance Biopharma, Inc. (TBPH). It has been studied in a Phase 1 clinical trial in healthy adult subjects, evaluating safety, tolerability, and pharmacokinetics. The program is in early clinical development and no specific disease indication has been disclosed.
TD-1473 is being developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company sponsored the Phase 1 study of TD-1473 conducted in the United States.
TD-1473 is in Phase 1 development. A single Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
TD-1473 was evaluated in one completed Phase 1 trial, NCT02657122, titled a single and multiple ascending dose study to assess safety, tolerability, and pharmacokinetics in healthy subjects. The trial enrolled 72 participants in the United States, was randomized, double blind, and placebo controlled.
The TD-1473 Phase 1 trial, NCT02657122, was a randomized, double blind, placebo controlled study of single and multiple ascending doses in healthy volunteers. It enrolled 72 participants aged 19 years and older of all sexes and was conducted in the United States. The study has been completed.