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Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

NCT03075267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-01-19

Study results available
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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

Conditions

Interventions

DRUG

PT010 (BGF MDI) 320/14.4/9.6 µg

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.

DRUG

PT010 (BGF MDI) 160/14.4/9.6 µg

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.

DRUG

PT003 (GFF MDI) 14.4/9.6 µg

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.

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul M. Dorinsky, MD · Pearl Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2017-09-05
Completion
2017-09-05
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075267 on ClinicalTrials.gov