Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04150341 | Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response | PHASE2 | COMPLETED | 24 | — | — | Nov 6, 2019 | Sep 3, 2020 | Mar 18, 2022 | 2 | United Kingdom |
| NCT03652038 | Single and Multiple Ascending Dose Study of TD-8236 by Inhalation | PHASE1 | COMPLETED | 94 | — | — | Nov 7, 2018 | Jul 13, 2020 | Sep 30, 2021 | 2 | United Kingdom |
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...