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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
TD-8236
Placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Single ascending dose, SAD, Multiple ascending dose, MAD, Phase 1, first-in-human, TD-8236, asthma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

TD-8236 for SAD (Part A)

Placebo for SAD (Part A)

TD-8236 for MAD (Part B)

Placebo for MAD (Part B)

TD-8236 for Biomarker (Part C)

Placebo for Biomarker (Part C)

Arm Description

6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236

2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo

6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236.

2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo.

8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236.

8 subjects in 1 biomarker cohort will be randomized to receive placebo.

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events

Secondary Outcome Measures

Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC)
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)
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax)
Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax)
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)
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC)
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)
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax)
Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax)
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)

Full Information

First Posted
August 20, 2018
Last Updated
September 28, 2021
Sponsor
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT03652038
Brief Title
Single and Multiple Ascending Dose Study of TD-8236 by Inhalation
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
July 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Single ascending dose, SAD, Multiple ascending dose, MAD, Phase 1, first-in-human, TD-8236, asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TD-8236 for SAD (Part A)
Arm Type
Experimental
Arm Description
6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236
Arm Title
Placebo for SAD (Part A)
Arm Type
Placebo Comparator
Arm Description
2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo
Arm Title
TD-8236 for MAD (Part B)
Arm Type
Experimental
Arm Description
6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236.
Arm Title
Placebo for MAD (Part B)
Arm Type
Placebo Comparator
Arm Description
2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo.
Arm Title
TD-8236 for Biomarker (Part C)
Arm Type
Experimental
Arm Description
8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236.
Arm Title
Placebo for Biomarker (Part C)
Arm Type
Placebo Comparator
Arm Description
8 subjects in 1 biomarker cohort will be randomized to receive placebo.
Intervention Type
Drug
Intervention Name(s)
TD-8236
Intervention Description
Study drug to be administered via inhaler device
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to be administered via inhaler device
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC)
Description
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)
Time Frame
Day 1 through Day 4
Title
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax)
Description
Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Time Frame
Day 1 through Day 4
Title
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax)
Description
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)
Time Frame
Day 1 through Day 4
Title
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC)
Description
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)
Time Frame
Day 1 through Day 9
Title
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax)
Description
Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Time Frame
Day 1 through Day 9
Title
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax)
Description
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)
Time Frame
Day 1 through Day 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Theravance Biopharma Investigational Site
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
Theravance Biopharma Investigational Site
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

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

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