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

NCT03652038 | Completed Phase 1 FDA Drug

• 2 other identifiers: 01752018-001260-38
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

Single ascending dose; SAD; Multiple ascending dose; MAD; Phase 1; first-in-human; TD-8236; asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax)

  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)

  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)

  Day 1 through Day 9

• Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax)

  Day 1 through Day 9

Study Arms (6)

TD-8236 for SAD (Part A)

EXPERIMENTAL

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

Drug: TD-8236

Placebo for SAD (Part A)

PLACEBO COMPARATOR

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

Drug: Placebo

TD-8236 for MAD (Part B)

EXPERIMENTAL

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

Drug: TD-8236

Placebo for MAD (Part B)

PLACEBO COMPARATOR

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

Drug: Placebo

TD-8236 for Biomarker (Part C)

EXPERIMENTAL

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

Drug: TD-8236

Placebo for Biomarker (Part C)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TD-8236 DRUG

Study drug to be administered via inhaler device

TD-8236 for Biomarker (Part C); TD-8236 for MAD (Part B); TD-8236 for SAD (Part A)

Placebo DRUG

Placebo to be administered via inhaler device

Placebo for Biomarker (Part C); Placebo for MAD (Part B); Placebo for SAD (Part A)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (2)

Theravance Biopharma Investigational Site

Manchester, England, M23 9QZ, United Kingdom

Location

Theravance Biopharma Investigational Site

Belfast, Northern Ireland, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 29, 2018
• Study Start: November 7, 2018
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)