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

NCT04350736 | Completed Phase 1

• 2 other identifiers: 01832020-000577-24
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

Acute lung injury; ALI; COVID-19; Coronavirus Disease 2019; inflammatory lung conditions; Inflammatory lung disease

Outcome Measures

Primary Outcomes (2)

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

  Number and severity of treatment emergent adverse events

  Day 1 to Day 8

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

  Number and severity of treatment emergent adverse events

  Day 1 to Day 14

Secondary Outcomes (6)

• 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 Single Ascending Dose (SAD): Cmax

  Day 1 through Day 4

• 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 Multiple Ascending Dose (MAD): AUC

  Day 1 through Day 9

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

  Day 1 through Day 9

Study Arms (4)

TD-0903 for SAD (Part A)

EXPERIMENTAL

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

Drug: TD-0903

Placebo for SAD (Part A)

EXPERIMENTAL

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

Drug: Placebo

TD-0903 for MAD (Part B)

EXPERIMENTAL

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

Drug: TD-0903

Placebo for MAD (Part B)

EXPERIMENTAL

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

Drug: Placebo

Interventions

TD-0903 DRUG

Study drug to be administered by inhalation

TD-0903 for MAD (Part B); TD-0903 for SAD (Part A)

Placebo DRUG

Placebo to be administered by inhalation

Placebo for MAD (Part B); Placebo for SAD (Part A)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Theravance Biopharma Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Acute Lung Injury; COVID-19

Interventions

nezulcitinib

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, placebo-controlled

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 23, 2020
• Primary Completion: June 24, 2020
• Study Completion: July 1, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)