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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Sequence 1 | Placebo Comparator | Treatment Period 1: Placebo Capsule will be administered orally. Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally. |
|
| Intervention Sequence 2 | Placebo Comparator | Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally. Treatment Period 2: Placebo Capsule will be administered orally. |
|
| Intervention Sequence 3 | Experimental | Treatment Period 1: AQ280 Capsule will be administered orally. Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally. |
|
| Intervention Sequence 4 | Experimental | Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally. Treatment Period 2: AQ280 Capsule will be administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQ280 Capsule | Drug | AQ280 administered orally in capsule formulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension | Ratio values were derived based on values for AUC0-Inf of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Ratio of Cmax for AQ280 Capsule vs Oral Suspension | Ratio values were derived based on values for Cmax of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞ of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) | AUC0-tlast of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Maximum Observed Concentration (Cmax) | Cmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Time of the Maximum Observed Concentration (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events | Incidence and severity of adverse events to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
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Inclusion Criteria -
Male or female, of any race, between 18 and 65 years of age, inclusive.
Body mass index between 18.0 and 29.9 kg/m2, inclusive.
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.
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
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 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).
Any of the following:
Participants with an increased risk of thromboembolic events (eg, history of recurrent venous thrombosis or Factor V Leiden mutation).
Magnesium < LLN; participants with values that are borderline < LLN may be included, as determined by the investigator or designee.
History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP.
AST and/or ALT values > 1.2 × ULN.
Congenital nonhemolytic hyperbilirubinemia.
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.
White blood cell count > ULN; participants with values that are borderline > ULN may be included, as determined by the investigator or designee.
eGFR < 90 mL/min/1.73 m2 (calculated using the CKD-EPI equation3).
Significant history of herpes infection (ie, severe herpes outbreaks requiring anti-viral treatment).
Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
Current active tuberculosis based on Quantiferonâ„¢ tuberculosis Gold test or history of latent infection.
Prior and Concomitant Therapy
Administration of any vaccine within 30 days prior to dosing.
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.
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.
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.
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
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.
Have previously completed or withdrawn from this study or any other study investigating AQ280 and have previously received AQ280.
Diet and Lifestyle
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.
Positive urine drug screen at screening. Positive alcohol test result or positive urine drug screen at check-in.
History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
Other
Use of tobacco- or nicotine-containing products within 3 months prior to check-in.
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.
Participants who, in the opinion of the investigator or designee, should not participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Törnell | AQILION AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Sequence 1 | Treatment Period 1: Placebo Capsule will be administered orally. Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally. Placebo Capsule: Placebo administered orally in capsule formulation. Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2025 | Jan 19, 2026 |
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| AQ280 Tablet for Oral Suspension | Drug | AQ280 administered orally in tablet for oral suspension formulation. |
|
| Placebo Capsule | Drug | Placebo administered orally in capsule formulation. |
|
| Placebo Tablet for Oral Suspension | Drug | Placebo administered orally in tablet for oral suspension formulation. |
|
Tmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation |
| Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Apparent Terminal Elimination Half-life (t1/2) | T1/2 of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Apparent Total Clearance (CL/F) | CL/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) | Vz/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Number of Participants With Abnormal Electrocardiograms |
QTcF interval of >500 msec or change from baseline (Day 1, predose) >60 msec |
| Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Systolic in mm Hg) | Number of participants with clinically significant abnormalities in vital signs - blood pressure (systolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Diastolic in mm Hg) | Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs - Pulse Rate (Beats Per Minute) | Number of participants with clinically significant abnormalities in vital signs - pulse rate (beats per minute) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs - Oral Body Temperature (°C) | Number of participants with clinically significant abnormalities in vital signs - oral body temperature (°C) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| Incidence of Abnormal Physical Examinations | Incidence of abnormal physical examinations to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. Any clinically significant findings observed during physical examinations following dose administration were reported as adverse events. | From screening up to end of study (approximately 7 weeks) |
| FG001 |
| Intervention Sequence 2 |
Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally. Treatment Period 2: Placebo Capsule will be administered orally. Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation. Placebo Capsule: Placebo administered orally in capsule formulation. |
| FG002 | Intervention Sequence 3 | Treatment Period 1: AQ280 Capsule will be administered orally. Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally. AQ280 Capsule: AQ280 administered orally in capsule formulation. AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation. |
| FG003 | Intervention Sequence 4 | Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally. Treatment Period 2: AQ280 Capsule will be administered orally. AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation. AQ280 Capsule: AQ280 administered orally in capsule formulation. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Sequence 1 | Treatment Period 1: Placebo Capsule will be administered orally. Treatment Period 2: Placebo Tablet for Oral Suspension will be administered orally. Placebo Capsule: Placebo administered orally in capsule formulation. Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation. |
| BG001 | Intervention Sequence 2 | Treatment Period 1: Placebo Tablet for Oral Suspension will be administered orally. Treatment Period 2: Placebo Capsule will be administered orally. Placebo Tablet for Oral Suspension: Placebo administered orally in tablet for oral suspension formulation. Placebo Capsule: Placebo administered orally in capsule formulation. |
| BG002 | Intervention Sequence 3 | Treatment Period 1: AQ280 Capsule will be administered orally. Treatment Period 2: AQ280 Tablet for Oral Suspension will be administered orally. AQ280 Capsule: AQ280 administered orally in capsule formulation. AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation. |
| BG003 | Intervention Sequence 4 | Treatment Period 1: AQ280 Tablet for Oral Suspension will be administered orally. Treatment Period 2: AQ280 Capsule will be administered orally. AQ280 Tablet for Oral Suspension: AQ280 administered orally in tablet for oral suspension formulation. AQ280 Capsule: AQ280 administered orally in capsule formulation. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratio of AUC0-Inf for AQ280 Capsule vs Oral Suspension | Ratio values were derived based on values for AUC0-Inf of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | Ratio of AUC0-Inf for AQ280 Cap vs Tab | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
|
| |||||||||||||||||||||||||
| Primary | Ratio of Cmax for AQ280 Capsule vs Oral Suspension | Ratio values were derived based on values for Cmax of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | Ratio of Cmax for AQ280 Cap vs Tab | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞ of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | h*ng/mL | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) | AUC0-tlast of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | h*ng/mL | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Maximum Observed Concentration (Cmax) | Cmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | ng/mL | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Time of the Maximum Observed Concentration (Tmax) | Tmax of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | h | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Apparent Terminal Elimination Half-life (t1/2) | T1/2 of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | h | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Apparent Total Clearance (CL/F) | CL/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | L/h | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Apparent Volume of Distribution During the Terminal Phase (Vz/F) | Vz/F of relative bioavailability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Standard Deviation | L | Pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Adverse Events | Incidence and severity of adverse events to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Safety Analysis Set | Posted | Count of Participants | Participants | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Electrocardiograms | QTcF interval of >500 msec or change from baseline (Day 1, predose) >60 msec | Safety Analysis Set | Posted | Count of Participants | Participants | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Systolic in mm Hg) | Number of participants with clinically significant abnormalities in vital signs - blood pressure (systolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Safety Analysis Set | Posted | Count of Participants | Participants | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs - Blood Pressure (Diastolic in mm Hg) | Number of participants with clinically significant abnormalities in vital signs - blood pressure (diastolic in mm Hg) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Safety Analysis Set | Posted | Count of Participants | Participants | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs - Pulse Rate (Beats Per Minute) | Number of participants with clinically significant abnormalities in vital signs - pulse rate (beats per minute) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Safety Analysis Set | Posted | Count of Participants | Participants | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs - Oral Body Temperature (°C) | Number of participants with clinically significant abnormalities in vital signs - oral body temperature (°C) to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation | Safety Analysis Set | Posted | Count of Participants | Participants | Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Incidence of Abnormal Physical Examinations | Incidence of abnormal physical examinations to assess the safety and tolerability of single oral doses of 100 mg AQ280 capsule formulation and 100 mg AQ280 tablet for oral suspension formulation. Any clinically significant findings observed during physical examinations following dose administration were reported as adverse events. | Safety Analysis Set | Posted | Count of Participants | Participants | From screening up to end of study (approximately 7 weeks) |
|
Screening, Day -1, pre dose and up to 48 hours post dose (up to end of study - approximately 7 weeks)
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after dosing or started prior to dosing and increased in severity after dosing.
A treatment-related TEAE was defined as a TEAE with a relationship of possibly related, or related to the treatment, as determined by the investigator.
All TEAEs considered related to administration of the study intervention are summarized for the safety set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | AQ280 Capsule | Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | AQ280 Tablet for Oral Suspension | Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2. | 0 | 6 | 0 | 6 | 2 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
The Sponsor Information, Inventions, Results and any other Deliverables are considered Sponsor Confidential Information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anneli Tinnerholm | Aqilion AB | +46 70 261 4575 | anneli.tinnerholm@aqilion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2025 | Jan 19, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2. |
|
|
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2. |
|
|
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2. |
|
|
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|
Participants were randomized to 1 of 4 intervention sequences, such that 2 participants received placebo and 6 participants received AQ280. Half of the participants who were randomized to AQ280 received the capsule formulation in Treatment Period 1 followed by the tablet for oral suspension formulation in Treatment Period 2 while the other half received the tablet for oral suspension in Treatment Period 1 followed by the capsule formulation in Treatment Period 2.
|
|
| Severe |
|
| No Adverse Event |
|