Acute Lung Injury (ALI) Associated With COVID-19 Clinical Trial
Official title:
A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, SAD and MAD Study in Healthy Subjects to Evaluate the Safety, Tolerability, and PK of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
| Verified date | June 2021 |
| Source | Theravance Biopharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | July 1, 2020 |
| Est. primary completion date | June 24, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | Inclusion Criteria: - Body mass index (BMI) = 18.0 and = 32.0 kg/m2 at Screening and weighs at least 50 kg. - Medically healthy with no clinically significant medical history, physical examination, spirometry, vital signs or ECGs. - Forced expiratory volume in 1 second (FEV1) =80%. - No clinically significant abnormalities in the results of laboratory evaluations. - Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method. - Male subjects must agree to use condoms, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential. - Understands the correct technique for the use the nebulizer device(s). - Other inclusion criteria apply Exclusion Criteria: - History or presence of clinically significant medical or psychiatric condition. - Abnormal ECG measurements at Screening. - Any signs of respiratory tract infection within 6 weeks of Screening. - Subject who has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to Screening. - Positive test for SARS-CoV-2 - Subject has any condition of the oro-laryngeal or respiratory tract. - Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening - Additional exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Theravance Biopharma Investigational Site | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| Theravance Biopharma |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and Tolerability of SAD of TD-0903: Adverse Events | Number and severity of treatment emergent adverse events | Day 1 to Day 8 | |
| Primary | Safety and Tolerability of MAD of TD-0903: Adverse Events | Number and severity of treatment emergent adverse events | Day 1 to Day 14 | |
| Secondary | 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 | |
| Secondary | Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04402866 -
TD-0903 for ALI Associated With COVID-19
|
Phase 2 |