This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Theravance Biopharma Investigational Site
Manchester, United Kingdom
Safety and Tolerability of SAD of TD-0903: Adverse Events
Number and severity of treatment emergent adverse events
Time frame: Day 1 to Day 8
Safety and Tolerability of MAD of TD-0903: Adverse Events
Number and severity of treatment emergent adverse events
Time frame: Day 1 to Day 14
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC
Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax
Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax
Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC
Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Time frame: Day 1 through Day 9
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Time frame: Day 1 through Day 9
Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax
Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Time frame: Day 1 through Day 9