Asthma
Conditions
Keywords
Single ascending dose, SAD, Multiple ascending dose, MAD, Phase 1, first-in-human, TD-8236, asthma
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.
Interventions
DRUGTD-8236
Study drug to be administered via inhaler device
DRUGPlacebo
Placebo to be administered via inhaler device
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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): 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) |
Countries
United Kingdom
Outcome results
None listed