Comparing the Extent to Which AQ280 is Made Available in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation

NCT ID: NCT07093008

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-13
• Study Completion Date: 2025-07-22

Brief 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.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Sequence 1

Treatment Period 1: Placebo Capsule will be administered orally.

Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally.

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DRUG

Placebo administered orally in capsule formulation.

Placebo Tablet for Oral Suspension

Intervention Type: DRUG

Placebo administered orally in tablet for oral suspension formulation.

Intervention Sequence 2

Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally.

Treatment Period 2: Placebo Capsule will be administered orally.

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DRUG

Placebo administered orally in capsule formulation.

Placebo Tablet for Oral Suspension

Intervention Type: DRUG

Placebo administered orally in tablet for oral suspension formulation.

Intervention Sequence 3

Treatment Period 1: AQ280 Capsule will be administered orally.

Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally.

Group Type: EXPERIMENTAL

AQ280 Capsule

Intervention Type: DRUG

AQ280 administered orally in capsule formulation.

AQ280 Tablet for Oral Suspension

Intervention Type: DRUG

AQ280 administered orally in tablet for oral suspension formulation.

Intervention Sequence 4

Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally.

Treatment Period 2: AQ280 Capsule will be administered orally.

Group Type: EXPERIMENTAL

AQ280 Capsule

Intervention Type: DRUG

AQ280 administered orally in capsule formulation.

AQ280 Tablet for Oral Suspension

Intervention Type: DRUG

AQ280 administered orally in tablet for oral suspension formulation.

Interventions

AQ280 Capsule

AQ280 administered orally in capsule formulation.

Intervention Type: DRUG

AQ280 Tablet for Oral Suspension

AQ280 administered orally in tablet for oral suspension formulation.

Intervention Type: DRUG

Placebo Capsule

Placebo administered orally in capsule formulation.

Intervention Type: DRUG

Placebo Tablet for Oral Suspension

Placebo administered orally in tablet for oral suspension formulation.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AQILION AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Törnell

Role: STUDY_DIRECTOR

AQILION AB

Locations

Clinical Research Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

ARIA-2

Identifier Type: -

Identifier Source: org_study_id