Small study compares two ways to take experimental esophagitis drug
NCT ID NCT07093008
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested two different forms of the experimental drug AQ280 in 9 healthy adults. The goal was to see how well the body absorbs the drug when given as a capsule versus a tablet that dissolves in water. The results will help researchers decide which form to use in future studies for eosinophilic esophagitis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AQ280
- What this could lead to
- If successful, this study could help determine the best way to give AQ280 to patients with eosinophilic esophagitis in future trials.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only looks at how the drug is absorbed, not whether it works for the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
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Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria - 1. Male or female, of any race, between 18 and 65 years of age, inclusive. 1. Females must not be pregnant or lactating. 2. Males and females of childbearing potential must agree to use contraception 2. Body mass index between 18.0 and 29.9 kg/m2, inclusive. 3. 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. 4. 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 1. 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. 2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee. 3. 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). 4. Any of the following: 1. QTcF \>450 ms in males or \>470 ms in females, based on the longest value from the triplicate ECG measurements 2. QRS duration \>120 ms, based on the longest value from the triplicate ECG measurements 3. PR interval \>210 ms, based on the longest value from the triplicate ECG measurements 4. findings which would make QTc measurements difficult or QTc data uninterpretable 5. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome). 5. Participants with an increased risk of thromboembolic events (eg, history of recurrent venous thrombosis or Factor V Leiden mutation). 6. Magnesium \< LLN; participants with values that are borderline \< LLN may be included, as determined by the investigator or designee. 7. History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP. 8. AST and/or ALT values \> 1.2 × ULN. 9. Congenital nonhemolytic hyperbilirubinemia. 10. 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. 11. White blood cell count \> ULN; participants with values that are borderline \> ULN may be included, as determined by the investigator or designee. 12. eGFR \< 90 mL/min/1.73 m2 (calculated using the CKD-EPI equation3). 13. Significant history of herpes infection (ie, severe herpes outbreaks requiring anti-viral treatment). 14. Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included. 15. Current active tuberculosis based on Quantiferon™ tuberculosis Gold test or history of latent infection. Prior and Concomitant Therapy 16. Administration of any vaccine within 30 days prior to dosing. 17. 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. 18. 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. 19. 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. 20. 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 21. 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. 22. Have previously completed or withdrawn from this study or any other study investigating AQ280 and have previously received AQ280. Diet and Lifestyle 23. 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. 24. Positive urine drug screen at screening. Positive alcohol test result or positive urine drug screen at check-in. 25. History of alcoholism or drug/chemical abuse within 2 years prior to check-in. Other 26. Use of tobacco- or nicotine-containing products within 3 months prior to check-in. 27. Receipt of blood products within 2 months prior to check-in. 28. Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening. 29. Poor peripheral venous access. 30. Participants who, in the opinion of the investigator or designee, should not participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Research Site
Madison, Wisconsin, 53704, United States
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Other studies related to the condition(s) this trial covers.
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