Clinical Trials/NCT04350736

NCT04350736

Completed

Phase 1

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

Theravance Biopharma1 site in 1 country54 target enrollmentApril 23, 2020

ConditionsAcute Lung Injury (ALI) Associated With COVID-19 Inflammatory Lung Conditions Associated With COVID-19

InterventionsTD-0903 Placebo

DrugsTD-0903 Placebo

Overview

Phase: Phase 1
Intervention: TD-0903
Conditions: Acute Lung Injury (ALI) Associated With COVID-19
Sponsor: Theravance Biopharma
Enrollment: 54
Locations: 1
Primary Endpoint: Safety and Tolerability of SAD of TD-0903: Adverse Events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 23, 2020

End Date

July 1, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Theravance Biopharma

Responsible Party

Sponsor

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

Arms & Interventions

TD-0903 for SAD (Part A)

6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903

Intervention: TD-0903

Placebo for SAD (Part A)

2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo

Intervention: Placebo

TD-0903 for MAD (Part B)

8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903

Intervention: TD-0903

Placebo for MAD (Part B)

2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and Tolerability of SAD of TD-0903: Adverse Events

Time Frame: Day 1 to Day 8

Number and severity of treatment emergent adverse events

Safety and Tolerability of MAD of TD-0903: Adverse Events

Time Frame: Day 1 to Day 14

Number and severity of treatment emergent adverse events

Secondary Outcomes

Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC(Day 1 through Day 4)
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC(Day 1 through Day 9)
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax(Day 1 through Day 4)
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax(Day 1 through Day 4)
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax(Day 1 through Day 9)
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax(Day 1 through Day 9)