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COMPLETEDPHASE1

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

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)

NCT03652038•Theravance Biopharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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

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

Locations (2)

Theravance Biopharma Investigational Site

Manchester, England, United Kingdom

Theravance Biopharma Investigational Site

Belfast, Northern Ireland, United Kingdom

Key Dates

Start Date

November 7, 2018

Primary Completion Date

July 13, 2020

Completion Date

July 13, 2020

Last Updated

September 30, 2021

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

TD-8236

DRUG

Placebo

DRUG

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

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Asthma

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma