A Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge

Adovate

Summary

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.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Males and females ages 18-65 years, inclusive 2. History of well-controlled mild or moderate persistent asthma for at least 6 months prior to screening. 3. Well controlled asthma demonstrated by asthma control test (ACT) score ≥20 at Visit 1. 4. Reactivity to AMP, as determined in Protocol 19512 (Screening Protocol of Asthmatic, Allergic Rhinitic, or Control Participants for Experimental Challenges). Reactivity is defined as having a PC20 AMP at or before 80mg/mL. 5. Two replicable (within 2 dose doublings) AMP challenges. The two AMP challenges must occur within 28 day…

Interventions

Drug
ADO-5030
Single oral dose of ADO-5030.

Location

University of Virginia
Charlottesville, Virginia
ddm9q@uvahealth.org 434-982-3510

A Single-Center, Single-Arm, Phase 1b Study to Evaluate the Effects of ADO-5030 on a Bronchoconstriction Challenge

Summary

Eligibility

Interventions

Location

Compensation

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Details

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