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Trial record 1 of 61 for:    Theravance Biopharma
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First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04350736
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : May 25, 2020
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: double-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 : April 23, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


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




Primary Outcome Measures :
  1. Safety and Tolerability of SAD of TD-0903: Adverse Events [ Time Frame: Day 1 to Day 8 ]
    Number and severity of treatment emergent adverse events

  2. Safety and Tolerability of MAD of TD-0903: Adverse Events [ Time Frame: Day 1 to Day 14 ]
    Number and severity of treatment emergent adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC [ Time Frame: 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)

  2. Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax [ Time Frame: 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)

  3. Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax [ Time Frame: 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)

  4. Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC [ Time Frame: 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)

  5. Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax [ Time Frame: 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)

  6. Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350736


Contacts
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Contact: Theravance Biopharma Call Center 1-855-633-8479 medinfo@theravance.com

Locations
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United Kingdom
Theravance Biopharma Investigational Site Recruiting
Manchester, United Kingdom, M23 9QZ
Contact: Theravance Biopharma Call Center    1-855-633-8479    medinfo@theravance.com   
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT04350736    
Other Study ID Numbers: 0183
2020-000577-24 ( EudraCT Number )
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: May 25, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theravance Biopharma:
Acute lung injury
ALI
COVID-19
Coronavirus Disease 2019
inflammatory lung conditions
Inflammatory lung disease
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders