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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: TD-8236; Drug: Placebo

• Registration Number: NCT03652038
• Lead Sponsor: Theravance Biopharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Study Start: 2018-11-07
• Primary Completion: 2020-07-13
• Study Completion: 2020-07-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD-8236 for SAD (Part A)	TD-8236	6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236
Placebo for SAD (Part A)	Placebo	2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo
TD-8236 for MAD (Part B)	TD-8236	6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236.
Placebo for MAD (Part B)	Placebo	2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo.
TD-8236 for Biomarker (Part C)	TD-8236	8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236.
Placebo for Biomarker (Part C)	Placebo	8 subjects in 1 biomarker cohort will be randomized to receive placebo.

Primary Outcome Measures

Name	Time	Method
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
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 Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax)	Day 1 through Day 4	Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax)	Day 1 through Day 4	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)
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC)	Day 1 through Day 9	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)
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax)	Day 1 through Day 9	Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC)	Day 1 through Day 4	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)
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax)	Day 1 through Day 9	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)

Trial Locations

Locations (1)

Theravance Biopharma Investigational Site; 🇬🇧 Belfast, Northern Ireland, United Kingdom