Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001260-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-8236 | Drug | Study drug to be administered via inhaler device |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events | Day 1 through Day 8 | |
| To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events | Day 1 through Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC) | Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC) | Day 1 through Day 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theravance Biopharma Investigational Site | Manchester | England | M23 9QZ | United Kingdom | ||
| Theravance Biopharma Investigational Site |
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
8 subjects in 1 biomarker cohort will be randomized to receive placebo. |
|
| Placebo | Drug | Placebo to be administered via inhaler device |
|
| Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax) |
Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax) |
| Day 1 through Day 4 |
| Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax) | Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax) | Day 1 through Day 4 |
| Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC) | Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC) | Day 1 through Day 9 |
| Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax) | Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax) | Day 1 through Day 9 |
| Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax) | Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax) | Day 1 through Day 9 |
| Belfast |
| Northern Ireland |
| United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |