Safety in Asthma Patients study: ASY202
Official title Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
ClinicalTrials.gov ID: NCT07665892
What this study is testing
What is ASY202?
ASY202 is an investigational inhaled powder being studied to see if it is safe for people with asthma. is designed to deliver dihydroergotamine directly into the lungs through a special inhaler device.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a single inhaled dose of ASY202 is safe and how it moves through the body in adults with stable asthma.
- Who it's for
- You may be able to join if you are an adult with stable asthma.
- What's involved
- You will receive one inhaled dose of ASY202 and later a pretend inhaled dose, each on separate days. You will stay at the clinic for up to 24 hours after each dose for monitoring and blood tests.
- Time commitment
- The study lasts about two weeks with two clinic stays and a final follow‑up visit.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Adults aged 18-55 years
- Diagnosed asthma
- Stable asthma treatment
- Non smoker
- BMI 18.5-35 kg/m²
You likely can't join if
- 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
See the full eligibility 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
- 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...
- Pregnancy, breastfeeding, or unwillingness to use required contraception
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.