Eosinophilic Esophagitis (EoE)Phase 1NCT05485779

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

A Phase 1 study testing AQ280 in people with Eosinophilic Esophagitis (EoE), run by AQILION AB at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Eosinophilic Esophagitis (EoE)
What is being tested?: AQ280
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteUnited Kingdom
Study dates: 20 Jul 2022to 10 Jul 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must satisfy all of the following criteria at the screening visit (and/or at check-in, where noted):
Males or females, of any race, between 18 and 65 years of age, inclusive.
Body mass index between 18.0 and 32.0 kg/m2, inclusive.
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).
Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Who cannot join

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
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).
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
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.
History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP.

Show all 32Show fewer

Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values >1.2 × upper limit of normal (ULN).
Congenital nonhemolytic hyperbilirubinemia (including suspicion of Gilbert's syndrome).
Hemoglobin value, neutrophil count, and/or lymphocyte count <lower limit of normal.
Clinically significant abnormal ECG at screening or check-in.
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
Current active tuberculosis based on Quantiferon™ tuberculosis Gold test.
Prior/concomitant therapy
Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to the first dose of investigational medicinal product (IMP).
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).
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).
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).
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
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
Have previously completed or withdrawn from this study.
Diet and lifestyle
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.
Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
Smoking >5 cigarettes per day, on average, or use the equivalent tobacco- or nicotine containing products per day.
Ingestion of poppy seed , Seville orange , star fruit-, or grapefruit containing foods or beverages within 7 days prior to check-in.
Other exclusions
Receipt of blood products within 2 months prior to check-in.
Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
Poor peripheral venous access.
Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Fortrea Clinical Research Unit Ltd.
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

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

Conditions: Eosinophilic Esophagitis (EoE)
Being tested: AQ280, Placebo
Medical subject headings: Eosinophilic Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AQ280Drug
Dose form: capsule, hard
Strength: 3 to 100 mg
Method of administration: oral
PlaceboDrug
Active substance: none
Dose form: capsule, hard
Strength/dose: not applicable
Method of administration: oral

Study groups in NCT05485779
Study group	Role	What they receive
Part A (SAD): Group A1	Experimental	Single dose of AQ280, 3 mg or placebo Receives: Drug: AQ280; Drug: Placebo
Part A (SAD): Group A2	Experimental	Single dose of AQ280, dose to be determined (TBD) or placebo Receives: Drug: AQ280; Drug: Placebo
Part A (SAD): Group A3	Experimental	Single dose of AQ280, dose TBD or placebo Receives: Drug: AQ280; Drug: Placebo
Part A (SAD): Group A4	Experimental	Single dose of AQ280, dose TBD or placebo Receives: Drug: AQ280; Drug: Placebo
Part A (SAD): Group A5	Experimental	Single dose of AQ280, dose TBD or placebo Receives: Drug: AQ280; Drug: Placebo
Part B (MAD): Group B1	Experimental	AQ280 dose TBD or placebo, once daily (QD) for seven days Receives: Drug: AQ280; Drug: Placebo
Part B (MAD): Group B2	Experimental	AQ280 dose TBD or placebo, once daily (QD) for seven days Receives: Drug: AQ280; Drug: Placebo
Part B (MAD): Group B3	Experimental	AQ280 dose TBD or placebo, once daily (QD) for seven days Receives: Drug: AQ280; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A (SAD): Number of Treatment Emergent Adverse Events (TEAEs) by Participant
The number of participants who experienced a treatment-emergent event (TEAE) are presented.
Measured: Part A (SAD): Screening up to Day 8 for fasted cohorts and Day 18(±2) for fed/fasted cohorts
Part A (SAD): Number of Treatment Emergent Adverse Events (TEAEs) Experienced
The number of total events experienced by participants are presented.
Measured: Part A (SAD): Screening up to Day 8 for fasted cohorts and Day 18(±2) for fed/fasted cohorts
Part B (MAD): Number of Treatment Emergent Adverse Events (TEAEs) by Participant
The number of participants who experienced a treatment-emergent event (TEAE) are presented.
Measured: Part B (MAD): Screening up to Day 14(±3)
Part B (MAD): Number of Treatment Emergent Adverse Events (TEAEs) Experienced
The number of total TEAE events experienced by participants are presented.
Measured: Part B (MAD): Screening up to Day 14(±3)
Part A (SAD): Number of Participants With Clinically Significant Abnormalities in Vital Signs
The number of participants with clinically significant abnormalities in vital signs is presented.
Vital signs: systolic and diastolic blood pressure, pulse rate, and oral body temperature
Measured: Part A (SAD): Screening up to Day 3
Part A (SAD): Number of Participants With Abnormal ECG
The number of participants with abnormal electrocardiogram (ECG) results is presented.
Abnormal ECGs were considered to be those with a QTcF interval of greater than 450 msec for males and greater than 470 msec for females, or change from baseline of greater than 30 msec.
Measured: Part A (SAD): Screening up to Day 3
Part A (SAD): Number of Subjects With Clinically Significant Changes in Laboratory Evaluations
The number of participants with clinically significant changes in any laboratory evaluations (clinical chemistry, haematology, coagulation, or urinalysis) is presented.
Measured: Part A (SAD): Screening up to Day 3
Part B (MAD): Number of Participants With Clinically Significant Abnormalities in Vital Signs
The number of participants with clinically significant abnormalities in vital signs is presented.
Vital signs: systolic and diastolic blood pressure, pulse rate, and oral body temperature
Measured: Part B (MAD): Screening up to Day 14(±3)
Part B (MAD): Number of Participants With Abnormal ECG
The number of participants with abnormal electrocardiogram (ECG) results is presented.
Abnormal ECGs were considered to be those with a QTcF interval of greater than 450 msec for males and greater than 470 msec for females, or change from baseline of greater than 30 msec.
Measured: Part B (MAD): Screening up to Day 14(±3)
Part B (MAD): Number of Participants With Clinically Significant Changes in Laboratory Evaluations
The number of participants with clinically significant changes in any laboratory evaluations (clinical chemistry, haematology, coagulation, or urinalysis) is presented.
Measured: Part B (MAD): Screening up to Day 14(±3)

Secondary outcomes (11)

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
Primary PK parameters derived from plasma concentration-time profile of AQ280: area under the concentration time curve from time 0 extrapolated to infinity following Single Oral Dose Administration of 3, 9, 16, 48, and 60 mg AQ280 in a Fasted State and 16 mg AQ280 in a Fed State
Measured: Days 1, 2 and 3
Part A (SAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of AQ280: Maximum Observed Concentration (Cmax)
Part A (SAD) - Primary PK parameter derived from plasma concentration-time profile of AQ280: maximum observed concentration (Cmax) following Single Oral Dose Administration of 3, 9, 16, 48, and 60 mg AQ280 in a Fasted State and 16 mg AQ280 in a Fed State
Measured: Days 1, 2 and 3
Part A (SAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity
Area under the concentration time curve from time 0 extrapolated to infinity of metabolite AQ282 following single oral dose administration of 3, 9, 16, 48, and 60 mg AQ280 in a fasted state and 16 mg AQ280 in a fed state
Measured: Days 1, 2 and 3
Part A (SAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Maximum Observed Concentration (Cmax)
Maximum observed concentration (Cmax) of metabolite AQ282 following single oral dose administration of 3, 9, 16, 48, and 60 mg AQ280 in a fasted state and 16 mg AQ280 in a fed state
Measured: Days 1, 2 and 3
Part A (SAD) - Difference in Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity in Fasted State and in Fed State
Difference in area under the concentration time curve from time 0 extrapolated to infinity derived from plasma concentration-time profile of AQ280 in fasted state and in fed state to assess the effect of food on single oral doses of 16 mg AQ280.
The within-subject coefficient of variation is presented under the 16 mg fed results.
Measured: Days 1, 2 and 3
Part A (SAD) - Difference in Maximum Observed Concentration (Cmax) in Fasted State and in Fed State
Difference in maximum observed concentration (Cmax) derived from plasma concentration-time profile of AQ280 in fasted state and in fed state to assess the effect of food on single oral doses of 16 mg AQ280.
The within-subject coefficient of variation is presented under the 16 mg fed results.
Measured: Days 1, 2 and 3
Part B (MAD) - Primary PK Parameters Derived From Plasma Concentration-time Profile of AQ280: Accumulation Ratio (AR)
Accumulation ratio (AR) AQ280 following multiple oral dose administration of 9, 27, and 60 mg AQ280 once daily for 7 consecutive days in a fasted state on Day 7.
ARAUC = accumulation ratio based on area under the concentration-time curve over a dosing interval ARCmax = accumulation ratio based on maximum observed concentration
Measured: Day 1 to Day 7
Part B (MAD) - Primary PK Parameters Derived From Plasma Concentration-time Profile of AQ280: Area Under the Concentration Time Curve Over a Dosing Interval
Area under the concentration time curve over a dosing interval (AUCτ) following single oral administration of 9, 27, and 60 mg AQ280 in a fasted state (Day 1) and after multiple oral dose administration of 9, 27, and 60 mg AQ280 once daily for 7 consecutive days in a fasted state (Day 7).
Measured: Day 1 and Day 7
Part B (MAD) - Primary PK Parameters Derived From Plasma Concentration-time Profile of AQ280: Maximum Observed Concentration (Cmax)
Maximum observed concentration (Cmax) following single oral administration of 9, 27, and 60 mg AQ280 in a fasted state (Day 1) and after multiple oral dose administration of 9, 27, and 60 mg AQ280 once daily for 7 consecutive days in a fasted state (Day 7).
Measured: Day 1 and Day 7
Part B (MAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Area Under the Concentration Time Curve Over a Dosing Interval (AUCτ)
Area under the concentration time curve over a dosing interval (AUCτ) of metabolite AQ282 following single oral dose administration of 9, 27, and 60 mg AQ280 in a fasted state (Day 1) and multiple oral dose administration of 9, 27, and 60 mg AQ280 once daily for 7 consecutive days in a fasted state (Day 7).
Measured: Day 1 and Day 7
Part B (MAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Maximum Observed Concentration (Cmax)
Maximum observed concentration (Cmax) of metabolite AQ282 following single oral dose administration of 9, 27, and 60 mg AQ280 in a fasted state (Day 1) and multiple oral dose administration of 9, 27, and 60 mg AQ280 once daily for 7 consecutive days in a fasted state (Day 7).
Measured: Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202210 Jul 2023

First posted3 Aug 2022
Study start20 Jul 2022
Primary completion10 Jul 2023
Study completion10 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05485779
Sponsor's protocol ID: ARIA-1
Status last verified: Nov 2024
First submitted: 15 Jul 2022
Last updated: 24 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Active, not recruitingPhase 2
A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
Eosinophilic Esophagitis

All Eosinophilic Esophagitis (EoE) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05485779
Acronym / sponsor ID: ARIA-1
Conditions: Eosinophilic Esophagitis (EoE)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: AQILION ABIndustry (pharma, biotech, devices)
Study start: 20 Jul 2022 (actual)
Primary completion: 10 Jul 2023 (actual)
Study completion: 10 Jul 2023 (actual)
First posted: 3 Aug 2022 (actual)
Results: Posted 24 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Part A (SAD): Group A1	Experimental	Drug: AQ280, Drug: PlaceboSingle dose of AQ280, 3 mg or placebo
Part A (SAD): Group A2	Experimental	Drug: AQ280, Drug: PlaceboSingle dose of AQ280, dose to be determined (TBD) or placebo
Part A (SAD): Group A3	Experimental	Drug: AQ280, Drug: PlaceboSingle dose of AQ280, dose TBD or placebo
Part A (SAD): Group A4	Experimental	Drug: AQ280, Drug: PlaceboSingle dose of AQ280, dose TBD or placebo
Part A (SAD): Group A5	Experimental	Drug: AQ280, Drug: PlaceboSingle dose of AQ280, dose TBD or placebo
Part B (MAD): Group B1	Experimental	Drug: AQ280, Drug: PlaceboAQ280 dose TBD or placebo, once daily (QD) for seven days
Part B (MAD): Group B2	Experimental	Drug: AQ280, Drug: PlaceboAQ280 dose TBD or placebo, once daily (QD) for seven days
Part B (MAD): Group B3	Experimental	Drug: AQ280, Drug: PlaceboAQ280 dose TBD or placebo, once daily (QD) for seven days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects must satisfy all of the following criteria at the screening visit (and/or at check-in, where noted):
Males or females, of any race, between 18 and 65 years of age, inclusive.
Body mass index between 18.0 and 32.0 kg/m2, inclusive.
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).
Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.

Key exclusion criteria (32 listed)

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
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).
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AQ280Dose form: capsule, hard Strength: 3 to 100 mg Method of administration: oral	Drug	Part A (SAD): Group A1, Part A (SAD): Group A2, Part A (SAD): Group A3, Part A (SAD): Group A4, Part A (SAD): Group A5, Part B (MAD): Group B1, Part B (MAD): Group B2, Part B (MAD): Group B3
PlaceboActive substance: none Dose form: capsule, hard Strength/dose: not applicable Method of administration: oral	Drug	Part A (SAD): Group A1, Part A (SAD): Group A2, Part A (SAD): Group A3, Part A (SAD): Group A4, Part A (SAD): Group A5, Part B (MAD): Group B1, Part B (MAD): Group B2, Part B (MAD): Group B3

Primary outcome

Part A (SAD): Number of Treatment Emergent Adverse Events (TEAEs) by Participant
Time frame: Part A (SAD): Screening up to Day 8 for fasted cohorts and Day 18(±2) for fed/fasted cohorts
The number of participants who experienced a treatment-emergent event (TEAE) are presented.
Part A (SAD): Number of Treatment Emergent Adverse Events (TEAEs) Experienced
Time frame: Part A (SAD): Screening up to Day 8 for fasted cohorts and Day 18(±2) for fed/fasted cohorts
The number of total events experienced by participants are presented.
Part B (MAD): Number of Treatment Emergent Adverse Events (TEAEs) by Participant
Time frame: Part B (MAD): Screening up to Day 14(±3)
The number of participants who experienced a treatment-emergent event (TEAE) are presented.
Part B (MAD): Number of Treatment Emergent Adverse Events (TEAEs) Experienced
Time frame: Part B (MAD): Screening up to Day 14(±3)
The number of total TEAE events experienced by participants are presented.
Part A (SAD): Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Part A (SAD): Screening up to Day 3
The number of participants with clinically significant abnormalities in vital signs is presented. Vital signs: systolic and diastolic blood pressure, pulse rate, and oral body temperature
Part A (SAD): Number of Participants With Abnormal ECG
Time frame: Part A (SAD): Screening up to Day 3
The number of participants with abnormal electrocardiogram (ECG) results is presented. Abnormal ECGs were considered to be those with a QTcF interval of greater than 450 msec for males and greater than 470 msec for females, or change from baseline of greater than 30 msec.
Part A (SAD): Number of Subjects With Clinically Significant Changes in Laboratory Evaluations
Time frame: Part A (SAD): Screening up to Day 3
The number of participants with clinically significant changes in any laboratory evaluations (clinical chemistry, haematology, coagulation, or urinalysis) is presented.
Part B (MAD): Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Part B (MAD): Screening up to Day 14(±3)
The number of participants with clinically significant abnormalities in vital signs is presented. Vital signs: systolic and diastolic blood pressure, pulse rate, and oral body temperature
Part B (MAD): Number of Participants With Abnormal ECG
Time frame: Part B (MAD): Screening up to Day 14(±3)
The number of participants with abnormal electrocardiogram (ECG) results is presented. Abnormal ECGs were considered to be those with a QTcF interval of greater than 450 msec for males and greater than 470 msec for females, or change from baseline of greater than 30 msec.
Part B (MAD): Number of Participants With Clinically Significant Changes in Laboratory Evaluations
Time frame: Part B (MAD): Screening up to Day 14(±3)
The number of participants with clinically significant changes in any laboratory evaluations (clinical chemistry, haematology, coagulation, or urinalysis) is presented.

11 secondary outcomes

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
Time frame: Days 1, 2 and 3
Part A (SAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of AQ280: Maximum Observed Concentration (Cmax)
Time frame: Days 1, 2 and 3
Part A (SAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity
Time frame: Days 1, 2 and 3
Part A (SAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Maximum Observed Concentration (Cmax)
Time frame: Days 1, 2 and 3
Part A (SAD) - Difference in Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity in Fasted State and in Fed State
Time frame: Days 1, 2 and 3
Part A (SAD) - Difference in Maximum Observed Concentration (Cmax) in Fasted State and in Fed State
Time frame: Days 1, 2 and 3
Part B (MAD) - Primary PK Parameters Derived From Plasma Concentration-time Profile of AQ280: Accumulation Ratio (AR)
Time frame: Day 1 to Day 7
Part B (MAD) - Primary PK Parameters Derived From Plasma Concentration-time Profile of AQ280: Area Under the Concentration Time Curve Over a Dosing Interval
Time frame: Day 1 and Day 7
Part B (MAD) - Primary PK Parameters Derived From Plasma Concentration-time Profile of AQ280: Maximum Observed Concentration (Cmax)
Time frame: Day 1 and Day 7
Part B (MAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Area Under the Concentration Time Curve Over a Dosing Interval (AUCτ)
Time frame: Day 1 and Day 7
Part B (MAD) - Primary PK Parameter Derived From Plasma Concentration-time Profile of the AQ280 Main Metabolite, AQ282: Maximum Observed Concentration (Cmax)
Time frame: Day 1 and Day 7

Results and safety

Results posted to the registry on 24 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A (SAD): Placebo (Fasted)	8	8
Part A (SAD): 3 mg (Fasted)	6	6
Part A (SAD): 9 mg (Fasted)	6	6
Part A (SAD): Placebo (Fasted/Fed)	2	2
Part A (SAD): 16 mg (Fasted/Fed)	6	6
Part A (SAD): 48 mg (Fasted)	6	6
Part A (SAD): 60 mg (Fasted)	6	6
Part B (MAD): Placebo	7	6
Part B (MAD): 9 mg	7	6
Part B (MAD): 27 mg	6	6
Part B (MAD): 60 mg	6	5

Primary outcome: Part A (SAD): Number of Treatment Emergent Adverse Events (TEAEs) by Participant

Time frame: Part A (SAD): Screening up to Day 8 for fasted cohorts and Day 18(±2) for fed/fasted cohorts. Count of participants. Unit: Participants

Measure	Part A (SAD): Placebo (Fasted) n = 10	Part A (SAD): Placebo (Fed) n = 2	Part A (SAD): 3 mg (Fasted) n = 6	Part A (SAD): 9 mg (Fasted) n = 6	Part A (SAD): 16 mg (Fasted) n = 6	Part A (SAD): 16 mg (Fed) n = 6	Part A (SAD): 48 mg (Fasted) n = 6	Part A (SAD): 60 mg (Fasted) n = 6
Value	1	0	1	2	1	2	0	1

Population analysed: Safety population. The 'Part A (SAD): Placebo (Fasted)' cohort includes the 8 participants in the fasted only cohort as well as any AEs experienced by the 2 participants in the 'Part A (SAD): Placebo (Fasted/Fed)' cohort whilst in the fasting during Treatment Period 1. Any AEs experienced by these 2 participants during Treatment Period 2 (ie, the fed stage) only are listed separately under the cohort 'Part A (SAD): Placebo (Fed).

Primary outcome: Part A (SAD): Number of Treatment Emergent Adverse Events (TEAEs) Experienced

Time frame: Part A (SAD): Screening up to Day 8 for fasted cohorts and Day 18(±2) for fed/fasted cohorts. Number. Unit: events

Measure	Part A (SAD): Placebo (Fasted) n = 10	Part A (SAD): Placebo (Fed) n = 2	Part A (SAD): 3 mg (Fasted) n = 6	Part A (SAD): 9 mg (Fasted) n = 6	Part A (SAD): 16 mg (Fasted) n = 6	Part A (SAD): 16 mg (Fed) n = 6	Part A (SAD): 48 mg (Fasted) n = 6	Part A (SAD): 60 mg (Fasted) n = 6
Value	1	0	1	2	2	3	0	1

Primary outcome: Part B (MAD): Number of Treatment Emergent Adverse Events (TEAEs) by Participant

Time frame: Part B (MAD): Screening up to Day 14(±3). Count of participants. Unit: Participants

Measure	Part B (MAD): Placebo n = 7	Part B (MAD): 9 mg n = 7	Part B (MAD): 27 mg n = 6	Part B (MAD): 60 mg n = 6
Value	3	3	3	3

Population analysed: Safety Population

Primary outcome: Part B (MAD): Number of Treatment Emergent Adverse Events (TEAEs) Experienced

Time frame: Part B (MAD): Screening up to Day 14(±3). Number. Unit: events

Measure	Part B (MAD): Placebo n = 7	Part B (MAD): 9 mg n = 7	Part B (MAD): 27 mg n = 6	Part B (MAD): 60 mg n = 6
Value	7	6	8	4

Population analysed: Safety Population

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part A: up to 7 weeks, from screening up to safety follow up Part B: up to 8 weeks, from screening up to safety follow up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A (SAD): Placebo (Fasted)	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Part A (SAD): Placebo (Fed)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part A (SAD): 3 mg (Fasted)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A (SAD): 9 mg (Fasted)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A (SAD): 16 mg (Fasted)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A (SAD): 16 mg (Fed)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A (SAD): 48 mg (Fasted)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A (SAD): 60 mg (Fasted)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part B (MAD): Placebo	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7
Part B (MAD): 9 mg	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7
Part B (MAD): 27 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part B (MAD): 60 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Eosinophilic Esophagitis (EoE)

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Active, not recruitingPhase 2
A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
Eosinophilic Esophagitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jan Törnell, MD, PhD study director

AQILION AB

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AQ280 in people with Eosinophilic Esophagitis (EoE), run by AQILION AB at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A (SAD): Number of Treatment Emergent Adverse Events (TEAEs) by Participant (time frame: Part A (SAD): Screening up to Day 8 for fasted cohorts and Day 18(±2) for fed/fasted cohorts). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05485779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.