Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for use in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics in healthy volunteers.
TD-1473 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH.
TD-1473 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities.
TD-1473 has one completed Phase 1 trial, NCT02657122, titled 'SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects.' The trial enrolled 72 participants in the United States.
No, TD-1473 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, and it remains in clinical development.