CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 96 enrolled
Drug / intervention
PT010 (BGF MDI) 320/14.4/9.6 µg +2 moredrug
Likely dose
PT010 (BGF MDI) 320/14.4/9.6 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03075267
NCT03075267Phase 1Completed
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A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days

Pearl Therapeutics, Inc.·interventional·Posted Mar 9, 2017·Updated Jan 19, 2021

In Brief

A Phase 1 clinical trial evaluating PT010 (BGF MDI) 320/14.4/9.6 µg, PT010 (BGF MDI) 160/14.4/9.6 µg, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 96 participants across 1 site.

Detailed Summary

A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartApr 17, 2017
Primary CompletionSep 5, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.3 years ago

Interventions

PT010 (BGF MDI) 320/14.4/9.6 µgdrug

A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.

PT010 (BGF MDI) 160/14.4/9.6 µgdrug

A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.

PT003 (GFF MDI) 14.4/9.6 µgdrug

A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.