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

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Brief Title

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

Official Title

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, and Food Effect Evaluation Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of AQ280 in Healthy Subjects

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Part A (SAD): Number of treatment emergent adverse events (TEAEs) per subject

Secondary Outcome

 Part A (SAD) - Primary PK parameters derived from plasma concentration-time profile of AQ280: area under the concentration time curve from time 0 extrapolated to infinity

Condition

Eosinophilic Esophagitis (EoE)

Intervention

AQ280

Study Arms / Comparison Groups

 Part A (SAD): Group A1
Description:  Single dose of AQ280, 3 mg or placebo

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

64

Start Date

July 20, 2022

Completion Date

December 28, 2022

Primary Completion Date

December 23, 2022

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 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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jan Törnell, MD, PhD, 0046730881415, anneli.tinnerholm@aqilion.com

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT05485779

Organization ID

ARIA-1


Responsible Party

Sponsor

Study Sponsor

AQILION AB


Study Sponsor

Jan Törnell, MD, PhD, Study Director, AQILION AB


Verification Date

July 2022