Study identifier:PT010003-00
ClinicalTrials.gov identifier:NCT02197975
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days
COPD
Phase 1
Yes
PT010 Dose 1, PT010 Dose 2, Placebo MDI
All
20
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2018 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: PT010 Dose 1 PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. | Drug: PT010 Dose 1 PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. |
Experimental: PT010 Dose 2 PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. | Drug: PT010 Dose 2 PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. |
Placebo Comparator: Placebo MDI Placebo MDI. Administered as 2 inhalations | Drug: Placebo MDI Placebo MDI. Administered as 2 inhalations |