First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated Wit… (NCT04350736) | Clinical Trial Compass
CompletedPhase 1
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
United Kingdom54 participantsStarted 2020-04-23
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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 screen…
What they're measuring
1
Safety and Tolerability of SAD of TD-0903: Adverse Events
Timeframe: Day 1 to Day 8
2
Safety and Tolerability of MAD of TD-0903: Adverse Events