Status:
COMPLETED
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
Lead Sponsor:
Theravance Biopharma
Conditions:
Acute Lung Injury (ALI) Associated With COVID-19
Inflammatory Lung Conditions Associated With COVID-19
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04350736
Start Date
April 23 2020
End Date
July 1 2020
Last Update
July 1 2021
Active Locations (1)
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1
Theravance Biopharma Investigational Site
Manchester, United Kingdom, M23 9QZ