Comparing the Extent to Which AQ280 is Made Available in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation

NCT07093008 | Completed Phase 1 FDA Drug

• 1 other identifier: ARIA-2
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, investigator- and participant-blinded, placebo-controlled, randomized, crossover study to compare bioavailability of AQ280 following single oral doses of a capsule formulation versus a tablet for oral suspension formulation in healthy participants.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (8)

• Relative Bioavailability (Frel)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Maximum observed concentration (Cmax)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Time of the maximum observed concentration (Tmax)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Apparent terminal elimination half-life (t1/2)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Apparent total clearance (CL/F)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Apparent volume of distribution during the terminal phase (Vz/F)

  Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

Secondary Outcomes (8)

• Incidence and severity of adverse events

  From screening up to end of study (approximately 7 weeks)

• Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

  Screening, Day -1 and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Number of participants with abnormal electrocardiograms

  Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Number of participants with clinically significant abnormalities in vital signs - blood pressure (systolic in mm Hg)

  Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

• Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg)

  Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)

Study Arms (4)

Intervention Sequence 1

PLACEBO COMPARATOR

Treatment Period 1: Placebo Capsule will be administered orally. Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally.

Drug: Placebo Capsule; Drug: Placebo Tablet for Oral Suspension

Intervention Sequence 2

PLACEBO COMPARATOR

Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally. Treatment Period 2: Placebo Capsule will be administered orally.

Drug: Placebo Capsule; Drug: Placebo Tablet for Oral Suspension

Intervention Sequence 3

EXPERIMENTAL

Treatment Period 1: AQ280 Capsule will be administered orally. Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally.

Drug: AQ280 Capsule; Drug: AQ280 Tablet for Oral Suspension

Intervention Sequence 4

EXPERIMENTAL

Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally. Treatment Period 2: AQ280 Capsule will be administered orally.

Drug: AQ280 Capsule; Drug: AQ280 Tablet for Oral Suspension

Interventions

AQ280 Capsule DRUG

AQ280 administered orally in capsule formulation.

Intervention Sequence 3; Intervention Sequence 4

AQ280 Tablet for Oral Suspension DRUG

AQ280 administered orally in tablet for oral suspension formulation.

Intervention Sequence 3; Intervention Sequence 4

Placebo Capsule DRUG

Placebo administered orally in capsule formulation.

Intervention Sequence 1; Intervention Sequence 2

Placebo Tablet for Oral Suspension DRUG

Placebo administered orally in tablet for oral suspension formulation.

Intervention Sequence 1; Intervention Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, of any race, between 18 and 65 years of age, inclusive.
• Females must not be pregnant or lactating.
• Males and females of childbearing potential must agree to use contraception
• Body mass index between 18.0 and 29.9 kg/m2, inclusive.
• In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the investigator or designee.
• Able to comprehend and are willing to sign the ICF and abide by the study restrictions.

You may not qualify if:

• An individual who meets any of the following criteria at screening, unless otherwise stated, will be excluded from participation in this study:
• Medical Conditions
• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
• Any of the following:
• QTcF \>450 ms in males or \>470 ms in females, based on the longest value from the triplicate ECG measurements
• QRS duration \>120 ms, based on the longest value from the triplicate ECG measurements
• PR interval \>210 ms, based on the longest value from the triplicate ECG measurements
• findings which would make QTc measurements difficult or QTc data uninterpretable
• history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome).
• Participants with an increased risk of thromboembolic events (eg, history of recurrent venous thrombosis or Factor V Leiden mutation).
• Magnesium \< LLN; participants with values that are borderline \< LLN may be included, as determined by the investigator or designee.
• History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP.
• AST and/or ALT values \> 1.2 × ULN.

Sponsors & Collaborators

• AQILION AB: lead

Study Sites (1)

Clinical Research Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jan Törnell

  AQILION AB

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 30, 2025
• Study Start: June 13, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 22, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)