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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

TD-0903

Placebo

About this trial

This is an interventional treatment trial for Acute Lung Injury (ALI) Associated With COVID-19 focused on measuring Acute lung injury, ALI, COVID-19, Coronavirus Disease 2019, inflammatory lung conditions, Inflammatory lung disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

Theravance Biopharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

TD-0903 for SAD (Part A)

Placebo for SAD (Part A)

TD-0903 for MAD (Part B)

Placebo for MAD (Part B)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Number and severity of treatment emergent adverse events

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

Number and severity of treatment emergent adverse events

Secondary Outcome Measures

Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC

Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax

Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)

Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax

Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC

Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax

Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)

Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax

Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

Full Information

NCT ID

NCT04350736

First Posted

April 14, 2020

Last Updated

June 29, 2021

Sponsor

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT04350736

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

April 23, 2020 (Actual)

Primary Completion Date

June 24, 2020 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

double-blind, randomized, placebo-controlled

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TD-0903 for SAD (Part A)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo for SAD (Part A)

Arm Type

Experimental

Arm Description

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

Arm Title

TD-0903 for MAD (Part B)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo for MAD (Part B)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TD-0903

Intervention Description

Study drug to be administered by inhalation

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to be administered by inhalation

Primary Outcome Measure Information:

Title

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

Description

Number and severity of treatment emergent adverse events

Time Frame

Day 1 to Day 8

Title

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

Description

Number and severity of treatment emergent adverse events

Time Frame

Day 1 to Day 14

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC

Description

Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

Time Frame

Day 1 through Day 4

Title

Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax

Description

Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)

Time Frame

Day 1 through Day 4

Title

Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax

Description

Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

Time Frame

Day 1 through Day 4

Title

Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC

Description

Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

Time Frame

Day 1 through Day 9

Title

Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax

Description

Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)

Time Frame

Day 1 through Day 9

Title

Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax

Description

Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

Time Frame

Day 1 through Day 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Theravance Biopharma Investigational Site

City

Manchester

ZIP/Postal Code

M23 9QZ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

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

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