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 drug being developed by Theravance Biopharma, Inc. (ticker TBPH). It is a JAK3-targeted kinase inhibitor that has been studied in a Phase 1 first-in-human clinical trial. The specific medical conditions it is intended to treat have not been disclosed.
TD-5202 targets JAK3, a kinase enzyme. JAK3 belongs to the Janus kinase family of kinases, which are involved in signaling pathways that regulate immune cell function. By targeting JAK3, TD-5202 is designed as a kinase inhibitor, a class of small molecule drugs that block specific enzyme activity.
TD-5202 is being developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company is the sponsor of the clinical program for this investigational JAK3-targeted small molecule.
TD-5202 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program consisted of a single completed first-in-human study conducted in healthy volunteers.
TD-5202 has been evaluated in one clinical trial, NCT04044339, titled a Single and Multiple Ascending Dose, First-in-Human Study in Healthy Subjects. This Phase 1 trial was completed, enrolled 56 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.