Mode
Text Size
Log in / Sign up
Phase 1 N=9 Randomized Double-blind Basic Science

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

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search