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RecruitingPhase 1

Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of one inhaled dose of ASY202 and how the body processes it in adults with stable asthma. Each person will get ASY202 and a placebo (no active drug) in separate study periods. They will stay in a research unit for tests and safety checks after each dose.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–55.
  • Have diagnosed asthma.
  • Have stable asthma treatment.
  • Do not smoke.
  • Have a body mass index (BMI), a measure of weight compared with height, of 18.5–35.
  • Men and women who can become pregnant must agree to use accepted birth control.

Who can't join

  • An asthma flare in the past 3 months that needed steroids that treat the whole body, an emergency room visit, or a hospital stay.
  • An infection in the airways or lungs within 4 weeks before screening.
  • Use of steroids by mouth or vein, or other medicines not allowed in the study. Examples include medicines that affect the CYP3A4 enzyme, triptans, medicines that narrow blood vessels or affect heart rhythm, and theophylline.
  • Other lung diseases, such as COPD (a long-term disease that limits airflow), or problems that interfere with breathing tests.
  • Unstable asthma or safety concerns that have not been resolved before a dose.
  • Serious heart or blood vessel disease, or abnormal heart tracing (ECG) results that make the drug DHE unsafe.
  • Three or more risks for disease in the heart's arteries: high blood pressure, high cholesterol, smoking, obesity, diabetes, a strong family history, being a woman past menopause (including after surgery), or being a man over 40.
  • Pregnant, breastfeeding, or unwilling to use the required birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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 * Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids) * Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry * Unstable asthma or unresolved safety concerns before dosing * Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE * 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) * Pregnancy, breastfeeding, or unwillingness to use required contraception

Study sites (3)

AZ

CA

TX