allergic reaction histamine-induced skin response
Conditions
Interventions
None listed
Sponsors
Araim Pharmaceuticals, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be 18-65 years of age (inclusive); 2. Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive); 3. History of good physical and mental health; 4. Subject has no clinically significant abnormality on the electrocardiogram performed; 5. Subject is a non-smoker or has not used nicotine/nicotine-containing products for at least 3 months; 6. Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff; 7. Subject is willing to comply with study restrictions.;Renal patients: creatinin clearance between 30 and 60 mL/min, other criteria comparable to healthy volunteers.
Exclusion criteria
Exclusion criteria: 1. Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings; 2. Subject has a semi recumbent systolic blood pressure of >150 mmHg and or diastolic blood pressure of > 90 mmHg; 3. Subject has an estimated creatinin clearance 2 years ago and FSH > 25 IU/L), surgically sterilized (> 6 months ago), or hysterectomized; 7. History of alcoholism or substance abuse within three years prior to screening; 8. Positive drug or alcohol test; 9. Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week; 10. Subject is unable to refrain from or anticipates the use of prescription medication in the period beginning one week prior to administration of the initial dose of the study drug until the post study visit; 11. Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; 12. Subjects that received a vaccination or immunization within the last month; 13. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug; 14. Subject who has undergone major surgery within three months prior to screening; 15. Donation or loss of blood (> 500 mL) within 3 months prior to screening; 16. Subjects who have a reaction to the negative control of the histamine test when tested on Day -1; 17. Any abnormalities on the back of the subject which would interfere with the histamine skin prick test as judged by the investigator (e.g. persons with dermatographism, eczema, tattoos or with dark skin-tones which would inhibit clear determination of wheal and flare for histamine assay); 18. Inadequate venous accessibility as judged by clinicians (physician or nurse). 19. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.;Renal patients: criteria comparable with healthy volunteers, except for conditions related to chronic kidney disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of ARA 290 after multiple dosing. The pharmacokinetics of ARA 290 after multiple dosing. The suppression of histamine-induced wheal and flare by multiple doses of ARA 290 (part 1). Renal and endothelial function after a single iv or sc dose of ARA 290 (part 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| The effects of multiple doses of ARA 290 on renal function, by measuring creatinin clearance, protein excretion, endothelin-1 excretion, and fractional sodium excretion. The effects of multiple doses of ARA 290 on insulin resistance as measured by fasting insulin and glucose. | — |
Countries
Netherlands
Outcome results
None listed