SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects

NCT ID: NCT05485779

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2023-07-10

Brief Summary

The principal aim of this study is to obtain safety and tolerability data when AQ280 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.

Conditions

Eosinophilic Esophagitis (EoE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A (SAD): Group A1

Single dose of AQ280, 3 mg or placebo

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Part A (SAD): Group A2

Single dose of AQ280, dose to be determined (TBD) or placebo

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Part A (SAD): Group A3

Single dose of AQ280, dose TBD or placebo

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Part A (SAD): Group A4

Single dose of AQ280, dose TBD or placebo

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Part A (SAD): Group A5

Single dose of AQ280, dose TBD or placebo

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Part B (MAD): Group B1

AQ280 dose TBD or placebo, once daily (QD) for seven days

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Part B (MAD): Group B2

AQ280 dose TBD or placebo, once daily (QD) for seven days

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Part B (MAD): Group B3

AQ280 dose TBD or placebo, once daily (QD) for seven days

Group Type: EXPERIMENTAL

AQ280

Intervention Type: DRUG

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Placebo

Intervention Type: DRUG

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Interventions

AQ280

Dose form: capsule, hard

Strength: 3 to 100 mg

Method of administration: oral

Intervention Type: DRUG

Placebo

Active substance: none

Dose form: capsule, hard

Strength/dose: not applicable

Method of administration: oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects must satisfy all of the following criteria at the screening visit (and/or at check-in, where noted):

1. Males or females, of any race, between 18 and 65 years of age, inclusive.

2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.

3. In good health, determined by no clinically significant findings from medical history, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).

4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.

5. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Exclusion Criteria

Subjects will be excluded from the study if they satisfy any of the following criteria at the screening visit (or at check-in, where noted):

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 any surgical (eg, stomach or intestinal surgery or resection) or medical condition that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs. Uncomplicated appendectomy and hernia repair will be allowed. Cholecystectomy will not be allowed.

4. History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP.

5. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values >1.2 × upper limit of normal (ULN).

6. Congenital nonhemolytic hyperbilirubinemia (including suspicion of Gilbert's syndrome).

7. Hemoglobin value, neutrophil count, and/or lymphocyte count <lower limit of normal.

8. Clinically significant abnormal ECG at screening or check-in.

9. Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects whose results are compatible with prior immunization may be included at the discretion of the investigator

10. Current active tuberculosis based on Quantiferon™ tuberculosis Gold test.

Prior/concomitant therapy

11. Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to the first dose of investigational medicinal product (IMP).

12. 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 the first dose of IMP, unless deemed acceptable by the investigator (or designee).

13. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to the first dose of IMP, unless deemed acceptable by the investigator (or designee).

14. Use or intend to use slow release medications/products considered to still be active within 14 days prior to check in, unless deemed acceptable by the investigator (or designee).

15. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to check in, unless deemed acceptable by the investigator (or designee).

Prior/concurrent clinical study experience

16. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.

17. Have previously completed or withdrawn from this study.

Diet and lifestyle

18. Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.

19. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.

20. History of alcoholism or drug/chemical abuse within 2 years prior to check-in.

21. Smoking >5 cigarettes per day, on average, or use the equivalent tobacco- or nicotine containing products per day.

22. Ingestion of poppy seed , Seville orange , star fruit-, or grapefruit containing foods or beverages within 7 days prior to check-in.

Other exclusions

23. Receipt of blood products within 2 months prior to check-in.

24. Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.

25. Poor peripheral venous access.

26. Subjects 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, MD, PhD

Role: STUDY_DIRECTOR

AQILION AB

Locations

Fortrea Clinical Research Unit Ltd.

Leeds, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARIA-1

Identifier Type: -

Identifier Source: org_study_id