A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults

NCT07226362 | Completed Phase 1 FDA Drug

• 1 other identifier: VFC202-102
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1 clinical trial to evaluate the pharmacokinetics, relative bioavailability, safety and tolerability of DHE inhalation powder delivered by dry powder inhaler, DHE IV, and DHE nasal spray.

Conditions

Safety, and Tolerability

Keywords

Dihydroergotamine mesylate; Inhalation powder

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics: Area under the curve (AUC 0-t) of DHE

  Area under the concentration-time curve from time zero until the last observed plasma concentration of DHE (AUC 0-t)

  For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours

• Pharmacokinetics: Area under the curve (AUC 0-inf) of DHE

  Area under the concentration-time curve from time zero to infinity (extrapolated) of plasma concentrations of DHE (AUC 0-inf)

  For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours

• Pharmacokinetics: Peak plasma concentration (C max) of DHE

  Maximal observed plasma concentration of DHE (C max)

  For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours

Secondary Outcomes (25)

• Pharmacokinetics: Area under the curve (AUC 0-t) of 8'-OH-DHE

  For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

• Pharmacokinetics: Area under the curve (AUC 0-inf) of 8'-OH-DHE

  For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

• Pharmacokinetics: Peak plasma concentration (C max) of 8'-OH-DHE

  For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

• Pharmacokinetics: Time of peak maximal concentration (T max) of DHE and 8'-OH-DHE

  For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

• Pharmacokinetics: Terminal elimination half-life (T 1/2 el) of DHE and 8'-OH-DHE

  For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

Study Arms (4)

Treatment A: inhaled DHE low dose

EXPERIMENTAL

Low dose of DHE inhalation powder

Combination Product: DHE inhalation powder low dose administered via dry powder inhaler (DPI) device

Treatment B: inhaled DHE high dose

EXPERIMENTAL

High dose of DHE inhalation powder

Combination Product: DHE inhalation powder high dose administered via dry powder inhaler (DPI) device

Treatment C: intravenous DHE

ACTIVE COMPARATOR

1 mg DHE injected intravenously

Drug: DHE injected intravenously (1 mg); Drug: Metoclopramide 10mg

Treatment D: intranasal DHE

ACTIVE COMPARATOR

2 mg DHE nasal spray (Migranal®)

Drug: DHE 2 mg administered by nasal spray (Migranal®)

Interventions

DHE injected intravenously (1 mg) DRUG

A single dose of DHE injection consists of 1 mg/mL ampoule of DHE solution for slow intravenous administration.

Treatment C: intravenous DHE

DHE 2 mg administered by nasal spray (Migranal®) DRUG

A single vial of DHE nasal spray (Migranal®) contains 1 mL of 4 mg/mL DHE solution.

Treatment D: intranasal DHE

Metoclopramide 10mg DRUG

To prevent nausea caused by IV administration of DHE, participants will receive antiemetic pre-medication with metoclopramide 10 mg administered by slow intravenous push over 1-2 min, given 5 to 10 minutes prior to IV DHE dosing.

Treatment C: intravenous DHE

DHE inhalation powder low dose administered via dry powder inhaler (DPI) device COMBINATION_PRODUCT

The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder low dose formulation for oral inhalation

Treatment A: inhaled DHE low dose

DHE inhalation powder high dose administered via dry powder inhaler (DPI) device COMBINATION_PRODUCT

The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder high dose formulation for oral inhalation

Treatment B: inhaled DHE high dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet all the following criteria to be included in the study:
• Male or female, ≥ 18 and ≤ 55 years of age, with body mass index (BMI) \>18.5 and \< 32.0 kg/m2
• Healthy subjects
• Female subjects of non-childbearing potential or childbearing potential willing to use protocol required methods of contraception
• Current non-smoker
• Able to understand the study procedures and provide signed informed consent to participate in the study.

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Positive pregnancy test or lactating female subjects at screening or on Day 1 of each treatment period
• Clinically significant abnormal laboratory or serology test results
• History or current diagnosis of uncontrolled or significant cardiac disease
• Significant risk factors for cardiovascular disease
• Subject with abnormal lung function at screening
• History or current diagnosis of lung disease e.g. asthma, COPD
• Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient
• History of drug or alcohol abuse

Sponsors & Collaborators

• Aspeya Switzerland SA: lead

Study Sites (1)

Alliance for Multispecialty research (AMR)

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

Dihydroergotamine; Metoclopramide

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (open-label)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be enrolled and randomized on Day 1 to one of the 4 treatment sequences composed of 4 periods of the crossover design.

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: November 10, 2025
• Study Start: June 9, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)