Single and multiple ascending dose study of TD-8236 by inhalation
Research type
Research Study
Full title
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-8236 by Inhalation of Single Ascending Doses in Healthy Subjects (Part A) and Multiple Ascending Doses in Subjects with Stable, Mild Asthma (Part B) and Stable, Moderate-to-Severe Asthma (Part C)
IRAS ID
246157
Contact name
Dave Singh
Contact email
Sponsor organisation
Theravance Biopharma US, Inc.
Eudract number
2018-001260-38
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
TD-8236 is a potential new inhaled drug that is being developed for the treatment of asthma.
The study is designed to assess how safe and well tolerated the drug is in healthy volunteers and the target population. Samples will be collected to measure the levels of TD-8236 in blood and urine. Blood samples will also be taken to measure how TD-8236 affects the body. The planned doses have been selected based on pre-clinical studies. The decision on whether or not to escalate to each new dose level, and the dose, will be based on a formal review by the site Principal Investigator(s) and the Theravance Biopharma Dose Level Review Committee (DLRC).
The study consists of two parts:
Part A - A Single Ascending Dose (SAD) phase in healthy subjects.Part B - A Multiple Ascending Dose (MAD) phase in stable mild asthma subjects.
Part A will have up to 5 cohorts of 8 healthy subjects. Part B will have up to 6 cohorts. Cohorts 1-4 and Cohort 6 of Part B will include 8 subjects. Cohort 5 of Part B will include 20 subjects.
Dosing will take place over 7 days during the MAD phase of the study. Cohorts 1-4 will receive once daily inhaled doses for 7 days. Cohorts 5 and 6 will receive either once or twice daily doses Days 1-6 and once a day on Day 7.
In each study part, subjects will participate in only 1 cohort.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0292
Date of REC Opinion
25 Jun 2018
REC opinion
Favourable Opinion