Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-5202 · 1 trial · 1 indication
Area under the plasma concentration-time curve (AUC)
Maximum observed concentration (Cmax)
Time to reach maximum observed concentration (Tmax)
Oral Clearance (CL/F)
Terminal Phase Volume of Distribution(Vz/F)
Elimination Rate (Kel)
Halflife (t 1/2)
Area under the plasma concentration-time curve (AUC)
Maximum observed concentration (Cmax)
Time to reach maximum observed concentration (Tmax)
concentration at trough (after multiple dosing usually after reaching steady state) (C trough)
concentration at steady state (Css)
Oral clearance at steady state (CL/Fss)
Concentration minimum (after single dosing) (Cmin)
Terminal phase volume of distribution at steady state (Vz/Fss)
Elimination Rate (Kel)
Halflife (t 1/2)
| Arm | Type | Description |
|---|---|---|
| TD-5202 for SAD (Part A) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202 |
| Placebo for SAD (Part A) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo |
| TD-5202 for MAD (Part B) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202 |
| Placebo for MAD (Part B) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| TD-5202 | DRUG | Study Drug to be administered orally |
| Placebo | DRUG | Placebo to be administered orally |
Inclusion Criteria: * Male or female, 19 - 55 years old * Willing and able to give informed consent and comply with the study * Medically healthy with no clinically significant medical history * Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg * Women of child bearing potential must h...
TD-5202 is an investigational small molecule being developed by Theravance Biopharma, Inc. (TBPH). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.
TD-5202 is being studied for use in healthy subjects. It is an investigational small molecule in Phase 1 clinical development. The drug has not been approved for any indication and is still in early-stage clinical trials.
TD-5202 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker TBPH. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule.
TD-5202 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety, tolerability, and pharmacokinetics.
TD-5202 has one completed Phase 1 clinical trial, identified as NCT04044339. This was a first-in-human study titled "Single and Multiple Ascending Dose, First-in-Human Study in Healthy Subjects." The trial enrolled 56 participants in the United States and was randomized, double-blind, and placebo-controlled.
No, TD-5202 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has been studied in a completed Phase 1 trial in healthy volunteers, but it has not received regulatory approval for any use.