This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Theravance Biopharma Investigational Site
Scottsdale, Arizona, United States
Theravance Biopharma Investigational Site
Monroe, Louisiana, United States
Theravance Biopharma Investigational Site
Hermitage, Tennessee, United States
Theravance Biopharma Investigational Site
Treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more treatment-emergent Adverse Events (TEAE)
Time frame: Baseline to end of follow-up (a maximum of 42 days)
Moderate or Severe Treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more moderate or severe treatment-emergent Adverse Events (TEAE)
Time frame: Baseline to end of follow-up (a maximum of 42 days)
Serious Treatment-emergent Adverse Events (TEAE)
Number of participants who experience one or more serious treatment-emergent Adverse Events (TEAE)
Time frame: Baseline to end of follow-up (a maximum of 42 days)
Clinical Laboratory Measurements
Number of participants who experienced a Clinically Significant Clinical Laboratory Measurements
Time frame: Baseline to end of follow-up (a maximum of 42 days)
Electrocardiogram
Number of participants who experienced a Clinically Significant Electrocardiogram (ECG) Result
Time frame: Baseline to Day 14
Vital Signs
Number of participants who experienced a Clinically Significant Vital Sign Measurement
Time frame: Baseline to end of follow-up (a maximum of 42 days)
Cmax in plasma
Maximum Observed Plasma Concentration of TD-1473
Time frame: Day 1 and Day 14
Tmax in plasma
Time to Reach Maximum Observed Plasma Concentration (Cmax) of TD-1473
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Houston, Texas, United States
Theravance Biopharma Investigational Site
San Antonio, Texas, United States
Theravance Biopharma Investigational Site
Tbilisi, Georgia
Theravance Biopharma Investigational Site
Chisinau, Moldova
Theravance Biopharma Investigational Site
Bucharest, Romania
Time frame: Day 1 and Day 14
Tlast in plasma
Time to Last Quantifiable Concentration of TD-1473
Time frame: Day 1 and Day 14
Ctrough in plasma
Trough Concentration of TD-1473
Time frame: Day 14 (Pre-dose)
AUC0-4 in plasma
Area Under the Concentration-time Curve from Time Zero to 4 hours Post-Dose of TD-1473
Time frame: Day 1 and Day 14
Ctissue in plasma
Tissue Concentration of TD-1473
Time frame: Day 28
C-reactive protein (CRP)
Mean Change in Serum C-reactive Protein (CRP)
Time frame: Baseline, Day 14 and Day 28
Fecal Calprotectin
Mean Change in Fecal Calprotectin
Time frame: Baseline and Day 28
Partial Mayo score
Mean Change in Partial Mayo Score
Time frame: Baseline, Day 14 and Day 28