Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-06

Study Completion Date

2020-09-03

Brief Summary

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This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TD-8236 Dose A (low dose)

TD-8236 Dose A (QD x 14 days)

Group Type EXPERIMENTAL

TD-8236

Intervention Type DRUG

The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

TD-8236 Dose B (high dose)

TD-8236 Dose B (QD x 14 days)

Group Type EXPERIMENTAL

TD-8236

Intervention Type DRUG

The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

Placebo

Placebo (QD x 14 days)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

Interventions

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TD-8236

The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

Intervention Type DRUG

Placebo

The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, 18 to 65 years of age
* Willing and able to give informed consent and comply with study requirements
* Documented physician-diagnosed asthma for ≥ 4 months prior to Screening
* Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Screening.
* Women of child bearing potential must have a negative pregnancy test
* Males and females must use a highly efficient birth control method
* Pre-bronchodilator FEV1 ≥ 70% predicted
* Documented allergy to at least one common allergen
* Dual responder to inhaled bronchial challenges

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
* History of life-threatening asthma
* Uses or have used tobacco or nicotine-containing products within 6 months prior to screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No