Comparing the Availability of AQ280 in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation

NCT07093008 | Completed Phase 1 Results 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 (9)

• Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension

  Ratio values were derived based on values for AUC0-Inf of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.

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

• Ratio of Cmax for AQ280 Capsule vs Oral Suspension

  Ratio values were derived based on values for Cmax of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.

  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-∞)

  AUC0-∞ of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation

  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)

  AUC0-tlast of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation

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

• Maximum Observed Concentration (Cmax)

  Cmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation

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

• Time of the Maximum Observed Concentration (Tmax)

  Tmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation

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

• Apparent Terminal Elimination Half-life (t1/2)

  T1/2 of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation

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

• Apparent Total Clearance (CL/F)

  CL/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation

  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)

  Vz/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation

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

Secondary Outcomes (7)

• Incidence and Severity of Adverse Events

  Screening, Day -1, pre dose 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)

• Number of Participants With Clinically Significant Abnormalities in Vital Signs - Pulse Rate (Beats Per Minute)

  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

Results Point of Contact

• Title: Anneli Tinnerholm
• Organization: Aqilion AB

anneli.tinnerholm@aqilion.com

+46 70 261 4575

Study Officials

• Jan Törnell

  AQILION AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 1, 2026
• Results First Posted: June 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)