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

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: TD-8236

Study type: Interventional

Funder types: Industry

Identifiers

NCT03652038

2018-001260-38 (EudraCT Number)

0175

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 6 patient groups, including a placebo group

TD-8236 for SAD (Part A)

Experimental group

Description:

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

Treatment:

Drug: TD-8236

Placebo for SAD (Part A)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

TD-8236 for MAD (Part B)

Experimental group

Description:

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

Treatment:

Drug: TD-8236

Placebo for MAD (Part B)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

TD-8236 for Biomarker (Part C)

Experimental group

Description:

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

Treatment:

Drug: TD-8236

Placebo for Biomarker (Part C)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo