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

Sponsor

Theravance Biopharma (Industry)

Overall Status

Completed

CT.gov ID

NCT04350736

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

23.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury (ALI) Associated With COVID-19 Inflammatory Lung Conditions Associated With COVID-19	Drug: TD-0903 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

double-blind, randomized, placebo-controlleddouble-blind, randomized, placebo-controlled

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 23, 2020

Actual Primary Completion Date :

Jun 24, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TD-0903 for SAD (Part A) 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903	Drug: TD-0903 Study drug to be administered by inhalation
Experimental: Placebo for SAD (Part A) 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo	Drug: Placebo Placebo to be administered by inhalation
Experimental: TD-0903 for MAD (Part B) 8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903	Drug: TD-0903 Study drug to be administered by inhalation
Experimental: Placebo for MAD (Part B) 2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo	Drug: Placebo Placebo to be administered by inhalation

Outcome Measures

Primary Outcome Measures

Safety and Tolerability of SAD of TD-0903: Adverse Events [Day 1 to Day 8]
Number and severity of treatment emergent adverse events
Safety and Tolerability of MAD of TD-0903: Adverse Events [Day 1 to Day 14]
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 [Day 1 through Day 4]
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 [Day 1 through Day 4]
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 [Day 1 through Day 4]
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 [Day 1 through Day 9]
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 [Day 1 through Day 9]
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 [Day 1 through Day 9]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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