First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Acute Lung Injury (ALI) Associated With COVID-19; Inflammatory Lung Conditions Associated With COVID-19

Treatments: Drug: TD-0903; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04350736

0183

2020-000577-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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54 participants in 4 patient groups

TD-0903 for SAD (Part A)

Experimental group

Description:

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

Treatment:

Drug: TD-0903

Placebo for SAD (Part A)

Experimental group

Description:

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

Treatment:

Drug: Placebo

TD-0903 for MAD (Part B)

Experimental group

Description:

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

Treatment:

Drug: TD-0903

Placebo for MAD (Part B)

Experimental group

Description:

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

Treatment:

Drug: Placebo