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

Aspeya, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Safety in Asthma Patients

Treatments: Combination Product: Placebo; Combination Product: ASY202

Study type: Interventional

Funder types: Industry

Identifiers

NCT07665892

VFC202-103

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

ASY202, then placebo

Experimental group

Description:

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.

Treatment:

Combination Product: ASY202

Combination Product: Placebo

Placebo, then ASY202

Experimental group

Description:

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.

Treatment:

Combination Product: ASY202

Combination Product: Placebo