This is a Phase 1 study to learn about the safety and pharmacokinetics of the study drug in patients with asthma and whether the study drug has effect during a respiratory challenge.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Single oral dose of ADO-5030.
University of Virginia
Charlottesville, Virginia, United States
Change from baseline in PC20 AMP.
PC20 AMP is defined as the provocative concentration of AMP resulting in a 20% fall from baseline in FEV1. FEV1 is defined as the amount of air you can forcefully exhale in one second.
Time frame: As this is a single dose trial, the timeframe is the duration in which PC20 AMP is reached during the AMP Challenge with ADO-5030 on Day 1.
Frequency of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).
TEAEs are defined as all adverse events (AEs) that subjects report after the administration of ADO-5030. Frequency of TEAEs will be reported.
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Severity of ADO-5030 Treatment-Emergent Adverse Events (TEAEs).
TEAEs are defined as all adverse events (AEs) that subjects report after the administration of ADO-5030. Severity of TEAEs will be reported.
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Frequency of ADO-5030 Treatment-Related Adverse Events (TRAEs).
TRAEs are defined as adverse events (AEs) that subjects report after the administration of ADO-5030, and that are deemed related to ADO-5030 by the principal investigator (PI). Frequency of TRAEs will be reported.
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
Severity of ADO-5030 Treatment-Related Adverse Events (TRAEs).
TRAEs are defined as adverse events (AEs) that subjects report after the administration of ADO-5030, and that are deemed related to ADO-5030 by the principal investigator (PI). Severity of TRAEs will be reported.
Time frame: Administration of ADO-5030 to End of Study, assessed up to 9 days post-dose.
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Frequency of Adverse Events (AEs).
The frequency of all AEs reported by subjects will be reported.
Time frame: Enrollment to End of Study, assessed up to 9 days post-dose.
Severity of Adverse Events (AEs).
The severity of all AEs reported by the subject will be reported.
Time frame: Enrollment to End of Study, assessed up to 9 days post-dose.