Eosinophilic EsophagitisPhase 1NCT07093008
Comparing the Availability of AQ280 in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation
A Phase 1 study testing AQ280 Capsule and AQ280 Tablet for Oral Suspension in people with Eosinophilic Esophagitis, run by AQILION AB at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- AQ280 Capsule and AQ280 Tablet for Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2025to 22 Jul 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 41Show fewer
- 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.
- Congenital nonhemolytic hyperbilirubinemia.
- Hemoglobin value, neutrophil count (absolute), lymphocyte count (absolute), and/or platelet count < LLN; participants with values that are borderline < LLN may be included, as determined by the investigator or designee.
- White blood cell count > ULN; participants with values that are borderline > ULN may be included, as determined by the investigator or designee.
- eGFR < 90 mL/min/1.73 m2 (calculated using the CKD-EPI equation3).
- Significant history of herpes infection (ie, severe herpes outbreaks requiring anti-viral treatment).
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- Current active tuberculosis based on Quantiferon™ tuberculosis Gold test or history of latent infection.
- Prior and Concomitant Therapy
- Administration of any vaccine within 30 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any prescription medications/products, other than hormone replacement therapy, oral, implantable, transdermal, injectable, intravaginal, or intrauterine contraceptives, within 14 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any slow-release medications/products considered to still be active within 14 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Prior and Concurrent Clinical Study Experience
- Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 90 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
- Have previously completed or withdrawn from this study or any other study investigating AQ280 and have previously received AQ280.
- Diet and Lifestyle
- Alcohol consumption of >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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Investigator- and Participant-blinded, Placebo-Controlled, Randomized, Crossover Study to Assess the Relative Bioavailability of Two Formulations of AQ280 in Healthy Participants
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
- Being tested
- AQ280 Capsule, AQ280 Tablet for Oral Suspension, Placebo Capsule, Placebo Tablet for Oral Suspension
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQ280 CapsuleDrug
AQ280 administered orally in capsule formulation.
AQ280 Tablet for Oral SuspensionDrug
AQ280 administered orally in tablet for oral suspension formulation.
Placebo CapsuleDrug
Placebo administered orally in capsule formulation.
Placebo Tablet for Oral SuspensionDrug
Placebo administered orally in tablet for oral suspension formulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: AQ280 Capsule; Drug: AQ280 Tablet for Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Incidence and severity of adverse events to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Measured: 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
QTcF interval of >500 msec or change from baseline (Day 1, predose) >60 msec
Measured: 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)
Number of participants with clinically significant abnormalities in vital signs - blood pressure (systolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Measured: 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)
Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Measured: 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)
Number of participants with clinically significant abnormalities in vital signs - pulse rate (beats per minute) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Measured: 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 - Oral Body Temperature (°C)
Number of participants with clinically significant abnormalities in vital signs - oral body temperature (°C) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Measured: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Incidence of Abnormal Physical Examinations
Incidence of abnormal physical examinations to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation.
Any clinically significant findings observed during physical examinations following dose administration were reported as adverse events.
Measured: From screening up to end of study (approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start13 Jun 2025
- Primary completion16 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AQILION AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Törnell, Study director, AQILION AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093008
- Sponsor's protocol ID
- ARIA-2
- Status last verified
- Feb 2026
- First submitted
- 4 Jul 2025
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Investigator- and Participant-blinded, Placebo-Controlled, Randomized, Crossover Study to Assess the Relative Bioavailability of Two Formulations of AQ280 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07093008
- Acronym / sponsor ID
- ARIA-2
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AQILION ABIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Sequence 1 | Placebo comparator | Drug: Placebo Capsule, Drug: Placebo Tablet for Oral SuspensionTreatment Period 1: Placebo Capsule will be administered orally. Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally. |
| Intervention Sequence 2 | Placebo comparator | Drug: Placebo Capsule, Drug: Placebo Tablet for Oral SuspensionTreatment Period 1: Placebo Tablet for Oral Suspension will be administered orally. Treatment Period 2: Placebo Capsule will be administered orally. |
| Intervention Sequence 3 | Experimental | Drug: AQ280 Capsule, Drug: AQ280 Tablet for Oral SuspensionTreatment Period 1: AQ280 Capsule will be administered orally. Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally. |
| Intervention Sequence 4 | Experimental | Drug: AQ280 Capsule, Drug: AQ280 Tablet for Oral SuspensionTreatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally. Treatment Period 2: AQ280 Capsule will be administered orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, of any race, between 18 and 65 years of age, inclusive.
- 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.
Key exclusion criteria (41 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQ280 CapsuleAQ280 administered orally in capsule formulation. | Drug | Intervention Sequence 3, Intervention Sequence 4 |
| AQ280 Tablet for Oral SuspensionAQ280 administered orally in tablet for oral suspension formulation. | Drug | Intervention Sequence 3, Intervention Sequence 4 |
| Placebo CapsulePlacebo administered orally in capsule formulation. | Drug | Intervention Sequence 1, Intervention Sequence 2 |
| Placebo Tablet for Oral SuspensionPlacebo administered orally in tablet for oral suspension formulation. | Drug | Intervention Sequence 1, Intervention Sequence 2 |
Primary outcome
Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
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.
Ratio of Cmax for AQ280 Capsule vs Oral Suspension
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
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.
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
AUC0-∞ of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
AUC0-tlast of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Maximum Observed Concentration (Cmax)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Cmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Time of the Maximum Observed Concentration (Tmax)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Tmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Apparent Terminal Elimination Half-life (t1/2)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
T1/2 of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Apparent Total Clearance (CL/F)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
CL/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Vz/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation
7 secondary outcomes
Incidence and Severity of Adverse Events
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 - Oral Body Temperature (°C)
Time frame: Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
Incidence of Abnormal Physical Examinations
Time frame: From screening up to end of study (approximately 7 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Törnell study director
AQILION AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AQ280 Capsule and AQ280 Tablet for Oral Suspension in people with Eosinophilic Esophagitis, run by AQILION AB at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension (time frame: Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.