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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2020-07-13

Brief Summary

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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.

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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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TD-8236 for SAD (Part A)

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

Group Type EXPERIMENTAL

TD-8236

Intervention Type DRUG

Study drug to be administered via inhaler device

Placebo for SAD (Part A)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to be administered via inhaler device

TD-8236 for MAD (Part B)

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

Group Type EXPERIMENTAL

TD-8236

Intervention Type DRUG

Study drug to be administered via inhaler device

Placebo for MAD (Part B)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to be administered via inhaler device

TD-8236 for Biomarker (Part C)

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

Group Type EXPERIMENTAL

TD-8236

Intervention Type DRUG

Study drug to be administered via inhaler device

Placebo for Biomarker (Part C)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to be administered via inhaler device

Interventions

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TD-8236

Study drug to be administered via inhaler device

Intervention Type DRUG

Placebo

Placebo to be administered via inhaler device

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes