Safety in Asthma Patients
Conditions
Keywords
DHE, Dihydroergotamine Mesylate
Brief summary
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.
Interventions
COMBINATION_PRODUCTASY202
ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
COMBINATION_PRODUCTPlacebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
Sponsors
Aspeya, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Eligible participants will be randomized to one of two treatment sequences per the crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma. | Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours. | Percentage change from baseline in FEV1 over time measured by spirometry at predefined timepoints post-dose (5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours), following administration of investigational product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma. | Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours. | Change from baseline in FEV1 in absolute value at post-dose time points |
| Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma | Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours | Proportion of participants with ≥20%, ≥15%, ≥10% reduction in FEV1 from baseline at any of the post-dose time points. |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of a single dose of ASY202 2 mg compared with placebo in adults with asthma. | Up to 24 hours post dose and safety follow up to seven days after last dose | Incidence and severity of Treatment Emergent Adverse Events (TEAEs) |
| Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma. | Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration | AUC0-t, AUC0-inf, AUC0-30min and AUC0-2h of plasma concentrations of DHE and 8'-OH-DHE of DHE and its metabolite |
| Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma | Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration | Kel of plasma concentrations of DHE and 8'-OH-DHE |
Countries
United States
Contacts
CONTACTGuillaume Crespel
Outcome results
None listed