The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994, administered to patients with asthma can achieve a clinically meaningful increase in pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an acceptable safety profile. The study will characterize the bronchodilator effect, dose and safety of PL-3994 in a population of moderately severe, stable asthmatics following overnight withdrawal of beta-2 agonists.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
subcutaneous PL-3994, single dose, 4 escalating dose groups
Unnamed facility
Cranbury, New Jersey, United States
Change in Forced Expiratory Volume in one second (FEV1)
Serial spirometry measures, including FEV1, assessed at specified time periods over 12 hours post dose.
Time frame: Throughout 12 hours post dosing
Change in Forced Vital Capacity (FVC)
Serial spirometry measures, including FVC, assessed at specified time periods over 12 hours post dose.
Time frame: Throughout 12 hours post dosing
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