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

NCT07665892 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VFC202-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Safety in Asthma Patients

Keywords

DHE; Dihydroergotamine Mesylate

Outcome Measures

Primary Outcomes (1)

• Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.

  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.

  Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.

Secondary Outcomes (14)

• 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.

• 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.

• 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.

• 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

• 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

Study Arms (2)

ASY202, then placebo

EXPERIMENTAL

ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.

Combination Product: ASY202; Combination Product: Placebo

Placebo, then ASY202

EXPERIMENTAL

In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.

Combination Product: ASY202; Combination Product: Placebo

Interventions

Placebo COMBINATION_PRODUCT

Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

ASY202, then placebo; Placebo, then ASY202

ASY202 COMBINATION_PRODUCT

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).

ASY202, then placebo; Placebo, then ASY202

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Aspeya, Inc.: lead

Study Sites (3)

Sun City Clinical Research

Glendale, Arizona, 85304, United States

RECRUITING

CenExel- Anaheim Clinical trials LLC

Anaheim, California, 92801, United States

RECRUITING

Worldwide Clinical Trials- Early Phase Research Unit

San Antonio, Texas, 78217, United States

RECRUITING

Central Study Contacts

Guillaume Crespel

CONTACT

+ 41 78 688 05 43; clinicaltrials@aspeya.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomized to one of two treatment sequences per the crossover design

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 24, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (3)