A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to
Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With
and Without Oral Charcoal

Key Inclusion Criteria:

- Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board
(IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening
procedures are performed

- Male and female subjects 18 to 40 years of age, inclusive

- Be in good general health as determined by a thorough medical history and physical
examination, ECG, vital signs, and clinical laboratory evaluation

- Non-childbearing potential (ie, physiologically incapable of becoming pregnant,
including any female who is 2 years post-menopausal, or surgically sterile

- Male subjects who are sexually active must agree to use a double-barrier method of
contraception (condom with spermicide) from the first dose of randomized study drug
until 2 weeks after their last dose, and must not donate sperm during their study
participation period

- Screening laboratory tests must be within normal range or determined to not be
clinically significant by the Investigator.

- Demonstrate correct MDI administration technique

Key Exclusion Criteria:

- For female subjects, a positive serum human chorionic gonadotropin (hCG) test at
screening or a positive urine hCG at admission for any of the 4 Treatment Periods

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

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

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

- History of substance-related disorders (with the exception of caffeine-related and
nicotine-related disorders) within 1 year of screening

- History of smoking or the use of nicotine-containing products within 3 months of
screening by self-reporting

- A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening
or at the beginning of each Treatment Period

- Treatment with any prescription or non-prescription drugs including vitamins, herbal,
and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study
drug use

- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is
longer) prior to the beginning of the screening Period

- Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of
drug administration or who have been vaccinated with an attenuated live virus within 4
weeks of drug administration

- Any other condition and/or situation that causes the Investigator to deem a subject
unsuitable for the study (eg, inability to medically tolerate the study procedures, or
a subject's unwillingness to comply with study-related procedures)