Clinical trial NCT04350736: First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Lung Injury (ALI) Associated With COVID-19
Inflammatory Lung Conditions Associated With COVID-19
Keywords: Acute lung injury
ALI
COVID-19
Coronavirus Disease 2019
inflammatory lung conditions
Inflammatory lung disease
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2020-04-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: double-blind, randomized, placebo-controlled
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Safety and Tolerability of SAD of TD-0903: Adverse Events
timeFrame: Day 1 to Day 8
measure: Safety and Tolerability of MAD of TD-0903: Adverse Events
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC
timeFrame: Day 1 through Day 4
measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax
timeFrame: Day 1 through Day 4
measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax
timeFrame: Day 1 through Day 4
measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC
timeFrame: Day 1 through Day 9
measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax
timeFrame: Day 1 through Day 9
measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax
timeFrame: Day 1 through Day 9
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Theravance Biopharma Investigational Site
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: