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

NCT ID: NCT04350736

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-23
• Study Completion Date: 2020-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TD-0903 for SAD (Part A)

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

Group Type: EXPERIMENTAL

TD-0903

Intervention Type: DRUG

Study drug to be administered by inhalation

Placebo for SAD (Part A)

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo to be administered by inhalation

TD-0903 for MAD (Part B)

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

Group Type: EXPERIMENTAL

TD-0903

Intervention Type: DRUG

Study drug to be administered by inhalation

Placebo for MAD (Part B)

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo to be administered by inhalation

Interventions

TD-0903

Study drug to be administered by inhalation

Intervention Type: DRUG

Placebo

Placebo to be administered by inhalation

Intervention Type: DRUG

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).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Theravance Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

Theravance Biopharma Investigational Site

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

2020-000577-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0183

Identifier Type: -

Identifier Source: org_study_id