Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 55 Years|
Inclusion Criteria:The following inclusion criteria will be assessed at screening (within 28 days prior to the first drug administration): 1. Non-smoking, male and female subjects from 18 to 55 years of age. 2. Documented Positive skin allergy test during the last year. 3. History of hay fever, seasonal allergies, or rhinitis. 4. BMI ≥18 and <=30 kg/m2. 5. Females may be of childbearing or non-childbearing potential:
- - Childbearing potential: o Physically capable of becoming pregnant.
- - Non-childbearing potential: - Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or.
- - Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause.
Exclusion Criteria:Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- - Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to drug administration; - Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration; - Are pregnant (serum hCG consistent with pregnancy); or.
- - Are lactating.
- - ≥50 mL and <500 mL within 30 days prior to drug administration; - ≥500 mL within 56 days prior to drug administration.
- - Alpha-adrenergic blocking drugs (e.g., phentolamine); - Anti-arrhythmics; - Beta-adrenergic blocking drugs (e.g., propranolol); - Cardiac glycosides; - Diuretics; - Drugs having an effect on cytochrome P450 (CYP450); - Enzyme-altering drugs (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine, etc.); - Enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism; - Ergot alkaloids; - Levothyroxine sodium; - Monoamine oxidase inhibitors; - Oral or topical corticosteroids; - Phenylephrine; - Reserpine-type or clonidine-type antihypertensives; - Sodium cromoglycate; or.
- - Tricyclic antidepressants.
- - Nasal decongestants; - Nonsteroidal anti-inflammatory drugs (NSAIDs); or.
- - Oral or topical antihistamines.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Yoseph Caraco, Prof.|
|Principal Investigator Affiliation||Hadassah Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Study Design: Open-label, single-dose, two-period, three-treatment, fixed-sequence, comparative bioavailability study Study Population: Non-smoking, male and female subjects, from 18 to 55 years of age with known history of hay fever, seasonal allergies, or rhinitis during the last year.
Experimental: Adults with seasonal allergic rhinitis
Single administration of 1.6mg or 3.2 mg Epinephrine powder nasal spray, with or without allergenic challenge, and single IM 0.3 mg Epinephrine without allergenic challenge.
Drug: - Epinephrine Nasal Product, 1.6 mg
Single dose Nasal powder spray without allergen challenge
Drug: - Epinephrine nasal product, 1.6 mg + allergen
Single dose Nasal powder spray with allergen challenge
Drug: - Epinephrine Injection 0.3 mg
Drug: - Epinephrine Nasal Product, 3.2 mg
Twice dose Nasal powder spray without allergen challenge
Drug: - Epinephrine Nasal Product, 3.2 mg + allergen
Twice dose Nasal powder spray with allergen challenge
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.