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

• Status: Completed
• Trial end date: 2017-09-05
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pearl Therapeutics, Inc.
• Treatments: Budesonide; Formoterol Fumarate; Glycopyrrolate

Criteria

Inclusion Criteria:

• Male and female Chinese subjects 18-45 years of age

• Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.

A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception

-Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.

Exclusion Criteria:

• Pregnant or nursing female subjects or subjects who are trying to conceive

• Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study

• Subjects with a history of ECG abnormalities

• Subjects who have cancer that has not been in complete remission for at least 5 years

• Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator

• Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening

• Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator

• Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated

• History of substance-related disorders within 1 year of Screening

• History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting

• A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period

• Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days

• Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening

• Positive for Syphilis Antibody

• Subjects with any flu-like syndrome or other respiratory infections

• Recently vaccinated with an attenuated live virus