Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-8236 · 2 trials · 1 indication
Values are reported as a weighted mean derived by calculating the AUC change from baseline over the relative time interval, divided by the time interval.
| Arm | Type | Description |
|---|---|---|
| TD-8236 Dose A (low dose) | EXPERIMENTAL | TD-8236 Dose A (QD x 14 days) |
| TD-8236 Dose B (high dose) | EXPERIMENTAL | TD-8236 Dose B (QD x 14 days) |
| Placebo | PLACEBO_COMPARATOR | Placebo (QD x 14 days) |
| TD-8236 for SAD (Part A) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236 |
| Placebo for SAD (Part A) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo |
| TD-8236 for MAD (Part B) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236. |
| Placebo for MAD (Part B) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo. |
| TD-8236 for Biomarker (Part C) | EXPERIMENTAL | 8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236. |
| Placebo for Biomarker (Part C) | PLACEBO_COMPARATOR | 8 subjects in 1 biomarker cohort will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| TD-8236 | DRUG | The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods. |
| Placebo | DRUG | The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods. |
Inclusion Criteria: * Male or female, 18 to 65 years of age * Willing and able to give informed consent and comply with study requirements * Documented physician-diagnosed asthma for ≥ 4 months prior to Screening * Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Scr...
TD-8236 is an investigational small molecule being developed for the treatment of asthma. It is administered by inhalation and is currently in Phase 2 clinical development. The drug is being studied for its effects on allergen-induced asthmatic responses in patients with asthma.
TD-8236 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 of TD-8236 for the treatment of asthma.
TD-8236 is in Phase 2 clinical development for asthma. Two clinical trials have been completed, including a Phase 1 study and a Phase 2 study. The drug is investigational and has not been approved by regulatory authorities.
TD-8236 has been studied in two completed clinical trials. NCT03652038 was a Phase 1 single and multiple ascending dose study in healthy volunteers with asthma, enrolling 94 participants. NCT04150341 was a Phase 2 study evaluating the effect of inhaled TD-8236 on allergen-induced asthmatic response, enrolling 24 participants with asthma.
TD-8236 is administered by inhalation. The clinical trials for TD-8236 evaluated the drug in inhaled form, with studies conducted in the United Kingdom. The Phase 2 trial specifically assessed the effect of inhaled TD-8236 on allergen-induced asthmatic response.