Tests a new inhaled medicine, ASY202, in adults with asthma
Checks safety and how the body processes one inhaled dose of ASY202 in adults.
Plain-language title generated from the registry record
Registry title: Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
Key facts
- Where
- Anaheim, Glendale, and San Antonio, United StatesSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07665892, who can take part
Where in United States
- CenExel- Anaheim Clinical trials LLCAnaheim, United StatesTaking people
- Sun City Clinical ResearchGlendale, United StatesNo longer taking part
- Worldwide Clinical Trials- Early Phase Research UnitSan Antonio, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aspeya, Inc.
- Trial code
- NCT07665892
- Record updated
- 2 September 2026
- Original description
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.Read full original descriptionShow less
A Phase 1 Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single-dose of ASY202 in Adults With Asthma
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.
Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods.
During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours.
Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study.
A follow-up visit will occur after the last dose to assess ongoing safety and tolerability.
Inclusion: Adults aged 18-55 years; Diagnosed asthma; Stable asthma treatment; Non smoker; BMI 18.5-35 kg/m²; Women of childbearing potential and men agree to use acceptable contraception.
Exclusion: Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months; Respiratory tract infection within 4 weeks prior to screening; Use of oral or IV corticosteroids; Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry; Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE; Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids); Three or more risk factors for Coronary Artery Disease (CAD) (hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age); Unstable asthma or unresolved safety concerns before dosing; Pregnancy, breastfeeding, or unwillingness to use required contraception.