A trial to evaluate the safety, tolerability, and pharmacokinetics of AQ280 in healthy subjects
- Conditions
- Allergic reaction in the gulletDigestive Systemeosinophilic esophagitis (EoE)
- Registration Number
- ISRCTN14453297
- Lead Sponsor
- Aqilion AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 64
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 ICF and to abide by the study restrictions.
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. AST and/or ALT values >1.2 × ULN.
6. Congenital nonhemolytic hyperbilirubinaemia (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 (TB) Gold test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of TEAEs per subject daily from signed consent to end of trial<br>2. Clinically significant abnormalities in vital signs (systolic and diastolic blood pressure, pulse rate, and oral body temperature) multiple timepoints per day from screening until end of trial<br>3. Abnormal ECG (QTcF interval of >450 msec for males and >470 msec for females, or change from baseline of >30 msec) measured from Day 1 (postdose) up until 48 hours postdose in Part A and up to the follow-up visit in Part B. Safety ECG: Part A/B: from screening and on Day 1, 3, 5, 7,8, 9<br>4. Clinically significant changes in laboratory evaluations on multiple days from dosing until end of trial
- Secondary Outcome Measures
Name Time Method Part A at predose and multiple timepoints up to 48 hours postdose:<br>1. Primary PK parameters derived from plasma concentration-time profile of AQ280: AUC0-8, Cmax (AUC0-t last may be included as a primary PK parameter if AUC0-8 cannot be calculated)<br>2. Primary PK parameters derived from plasma concentration-time profile of the AQ280 main metabolite, AQ282: AUC0-8, Cmax (AUC0-t last may be included as a primary PK parameter if AUC0-8 cannot be calculated)<br>3. Comparison of the primary PK parameters of AQ280 after single dose administration in the fasted state and in the fed state<br><br>Part B at predose and multiple timepoints during Day 1 and Day 7, as well as daily until end of trial:<br>1. Primary PK parameters derived from plasma concentration-time profile of AQ280 on Day 1 and Day 7: AR, AUCt, Cmax<br>2. Primary PK parameters derived from plasma concentration-time profile of the AQ280 main metabolite, AQ282, on Day 1 and Day 7: AUCt, Cmax