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Single and Multiple Ascending Dose Study of TD-8236 by Inhalation

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ClinicalTrials.gov Identifier: NCT03652038
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Study Description
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Brief Summary:
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: TD-8236 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-8236 by Inhalation of Single Ascending Doses in Healthy Subjects (Part A) and Multiple Ascending Doses in Subjects With Stable, Mild Asthma (Part B), and Stable, Moderate-to-Severe Asthma (Part C)
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : July 13, 2020
Actual Study Completion Date : July 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: TD-8236 for SAD (Part A)
6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236
 Drug: TD-8236
Study drug to be administered via inhaler device
Placebo Comparator: Placebo for SAD (Part A)
2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo
 Drug: Placebo
Placebo to be administered via inhaler device
Experimental: TD-8236 for MAD (Part B)
6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236.
 Drug: TD-8236
Study drug to be administered via inhaler device
Placebo Comparator: Placebo for MAD (Part B)
2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo.
 Drug: Placebo
Placebo to be administered via inhaler device
Experimental: TD-8236 for Biomarker (Part C)
8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236.
 Drug: TD-8236
Study drug to be administered via inhaler device
Placebo Comparator: Placebo for Biomarker (Part C)
8 subjects in 1 biomarker cohort will be randomized to receive placebo.
 Drug: Placebo
Placebo to be administered via inhaler device


Outcome Measures
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Primary Outcome Measures :
  1. To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events [ Time Frame: Day 1 through Day 8 ]
  2. To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events [ Time Frame: Day 1 through Day 14 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 through Day 4 ]

    Multiple PK variables of TD-8236 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-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax) [ Time Frame: Day 1 through Day 4 ]

    Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to:

    Maximum observed concentration (Cmax)


  3. Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax) [ Time Frame: Day 1 through Day 4 ]

    Multiple PK variables of TD-8236 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-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 through Day 9 ]

    Multiple PK variables of TD-8236 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-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax) [ Time Frame: Day 1 through Day 9 ]

    Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:

    Maximum observed concentration (Cmax)


  6. Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax) [ Time Frame: Day 1 through Day 9 ]

    Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:

    Time to reach maximum observed concentration (Tmax)



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 18 - 60 years old
  • Willing and able to give informed consent and comply with the study
  • Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
  • Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
  • Pre-bronchodilator FEV ≥ 70% predicted for MAD cohorts and >40% predicted for biomarker cohorts
  • Treatment with inhaled corticosteroids with or without long acting beta agonists
  • Additional inclusion criteria apply

Exclusion Criteria:

  • Positive for hepatitis A, B or C, HIV or tuberculosis
  • Clinically significant abnormalities of laboratory evaluations
  • Have abnormal ECG measurements
  • Any sign of respiratory tract infection within 6 weeks of screening
  • Have a current bacterial, parasitic, fungal or viral infection
  • Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
  • Additional exclusion criteria apply
Contacts and Locations
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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): NCT03652038


Locations
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United Kingdom
Theravance Biopharma Investigational Site
Manchester, England, United Kingdom, M23 9QZ
Theravance Biopharma Investigational Site
Belfast, Northern Ireland, United Kingdom
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma
More Information
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03652038    
Other Study ID Numbers: 0175
2018-001260-38 ( EudraCT Number )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
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: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Theravance Biopharma:
Single ascending dose
SAD
Multiple ascending dose
MAD
 Phase 1
first-in-human
TD-8236
asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases