CompletedPhase 1

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

United States9 participantsStarted 2025-06-13

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension

Timeframe: 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

Timeframe: 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-∞)

Timeframe: 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)

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

Maximum Observed Concentration (Cmax)

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

Time of the Maximum Observed Concentration (Tmax)

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

Trial details

NCT IDNCT07093008

SponsorAQILION AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-16

Results submitted2026-02-10

View on ClinicalTrials.gov More Eosinophilic Esophagitis trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension

Timeframe: 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

Timeframe: 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-∞)

Timeframe: 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)

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

Maximum Observed Concentration (Cmax)

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

Time of the Maximum Observed Concentration (Tmax)

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria