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

Phase 1CompletedNCT03652038

Theravance Biopharma94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

TD-8236DRUG

Study drug to be administered via inhaler device

PlaceboDRUG

Placebo to be administered via inhaler device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Theravance Biopharma Investigational Site

Manchester, England, United Kingdom

Theravance Biopharma Investigational Site

Belfast, Northern Ireland, United Kingdom

Outcomes

Primary Outcomes

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

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

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)

Time frame: Day 1 through Day 4

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)

Time frame: Day 1 through Day 4

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)

Time frame: Day 1 through Day 4

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)

Time frame: Day 1 through Day 9

Data from ClinicalTrials.gov

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