Phase 1
N=9
Comparing the Availability of AQ280 in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT07093008 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcome: Primary: Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension — 0.976 Ratio of AUC0-Inf for AQ280 Cap vs Tab
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AQ280 Capsule (Drug); AQ280 Tablet for Oral Suspension (Drug); Placebo Capsule (Drug); Placebo Tablet for Oral Suspension (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AQILION AB
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension |
0.976 | — |
| PRIMARY Ratio of Cmax for AQ280 Capsule vs Oral Suspension |
0.842 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) |
5070; 4950 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) |
5020; 4910 | — |
| PRIMARY Maximum Observed Concentration (Cmax) |
1190; 999 | — |
| PRIMARY Time of the Maximum Observed Concentration (Tmax) |
1.25; 0.911 | — |
| PRIMARY Apparent Terminal Elimination Half-life (t1/2) |
10.8; 8.18 | — |
| PRIMARY Apparent Total Clearance (CL/F) |
19.7; 20.2 | — |
| PRIMARY Apparent Volume of Distribution During the Terminal Phase (Vz/F) |
307; 239 | — |
| SECONDARY Incidence and Severity of Adverse Events |
2; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms |
1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Systolic in mm Hg) |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Diastolic in mm Hg) |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs - Pulse Rate (Beats Per Minute) |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs - Oral Body Temperature (°C) |
0; 0; 0 | — |
| SECONDARY Incidence of Abnormal Physical Examinations |
0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria -
- 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.
Exclusion Criteria -
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 1.2 × ULN.
- Congenital nonhemolytic hyperbilirubinemia.
- Hemoglobin value, neutrophil count (absolute), lymphocyte count (absolute), and/or platelet count ULN; participants with values that are borderline > ULN may be included, as determined by the investigator or designee.
- eGFR 21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive urine drug screen at screening. Positive alcohol test result or positive urine drug screen at check-in.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
Other
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in.
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Participants who, in the opinion of the investigator or designee, should not participate in this study.
Data sourced from ClinicalTrials.gov (NCT07093008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.