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

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652038
• Other study ID #: 0175
• Secondary ID: 2018-001260-38
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2018
• Est. completion date: July 13, 2020

Study information

• Verified date: September 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TD-8236
Study drug to be administered via inhaler device
• Placebo
Placebo to be administered via inhaler device

Locations

Country	Name	City	State
United Kingdom	Theravance Biopharma Investigational Site	Belfast	Northern Ireland
United Kingdom	Theravance Biopharma Investigational Site	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events		Day 1 through Day 8
Primary	To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events		Day 1 through Day 14
Secondary	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)	Day 1 through Day 4
Secondary	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)	Day 1 through Day 4
Secondary	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)	Day 1 through Day 4
Secondary	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)	Day 1 through Day 9
Secondary	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)	Day 1 through Day 9
Secondary	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)	Day 1 through Day 9