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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000577-24 | EudraCT Number |
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This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-0903 for SAD (Part A) | Experimental | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
|
| Placebo for SAD (Part A) | Experimental | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
|
| TD-0903 for MAD (Part B) | Experimental | 8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903 |
|
| Placebo for MAD (Part B) | Experimental | 2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-0903 | Drug | Study drug to be administered by inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of SAD of TD-0903: Adverse Events | Number and severity of treatment emergent adverse events | Day 1 to Day 8 |
| Safety and Tolerability of MAD of TD-0903: Adverse Events | Number and severity of treatment emergent adverse events | Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC | Multiple PK variables of TD-0903 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 |
| Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theravance Biopharma Investigational Site | Manchester | M23 9QZ | United Kingdom |
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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double-blind, randomized, placebo-controlled
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| Placebo | Drug | Placebo to be administered by inhalation |
|
Multiple PK variables of TD-0903 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-0903 when given as a Single Ascending Dose (SAD): Tmax | Multiple PK variables of TD-0903 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-0903 when given as a Multiple Ascending Dose (MAD): AUC | Multiple PK variables of TD-0903 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-0903 when given as a Multiple Ascending Dose (MAD): Cmax | Multiple PK variables of TD-0903 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-0903 when given as a Multiple Ascending Dose (MAD): Tmax | Multiple PK variables of TD-0903 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 |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000719753 | nezulcitinib |
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