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Completed

NCT Number: NCT03652038

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Theravance Biopharma Investigational Site, Manchester, England, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD-8236

Drug

Study drug to be administered via inhaler device

Placebo

Drug

Placebo to be administered via inhaler device

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2018
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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