Anaphylaxis, Food Allergy, Food Allergy Peanut, Food Hypersensitivity
Conditions
Keywords
Type 1 allergy, epinephrine, anaphylaxis, food allergy
Brief summary
This is an open-label, three-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray or drop in healthy adults. For all parts of the study, participants will undergo at least 10 hours of fasting prior to dosing. Part 1 of the study focuses on IN-001 dose/formulation exploration in a small number of participants (N=6); Part 2 of the study involving up to 12 participants will test a dose selected from Part 1 delivered as both a sublingual spray and a sublingual drop. In Part 3, one delivery method will be tested. Total number of participants is 30.
Interventions
DRUGEpinephrine Auto-Injector 0.3 mg/0.3 mL
Epinephrine injection
DRUGEpinephrine 0.3 mg intramuscular manual injection via a syringe and needle
Epinephrine injection
DRUGIN-001 9.06 mg Sublingual Spray
Sublingual Spray
DRUGIN-001 13.59 mg Sublingual Spray
Sublingual Spray
Sponsors
Insignis Therapeutics, Inc.
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* To participate in this trial, volunteers must meet all of the inclusion criteria listed below: 1. Age \> 18 years of age and \< 45 years of age. 2. Women of childbearing potential or men with childbearing potential partners must agree that the participant and/or their partner will use the following effective methods of birth control from screening visit until 14 days after the last dose of study drug: 1. Abstinence 2. Hormonal contraceptives for at least one month prior to Screening 3. Double barrier (e.g., diaphragm with spermicide, condom with spermicide) 4. Intrauterine device (IUD) 5. Surgically sterile (e.g., bilateral tubal ligation, total or partial hysterectomy, or bilateral oophorectomy) * Note: Females will be considered post-menopausal if they * are at least 45 years of age with amenorrhea for at least one year, or * received bilateral oophorectomy with or without a hysterectomy. 3. BMI \> 18.50 and \< 29.90 kg/m2 (using formula BMI = weight (kg)/height (m2). 4. All clinical laboratory test results (e.g., hematology, chemistry, urinalysis) are within normal limits or considered not clinically significant by Investigator. 5. Serum pseudocholinesterase activity is within normal limits or considered not clinically significant by Investigator. 6. Physical examination (excluding genital and rectal exams) is normal or considered not clinically significant by Investigator. 7. Vital signs measurements (pulse rate, blood pressure, temperature, and respiratory rate) are normal or considered not clinically significant by Investigator, while seated or semi-recumbent and after 5 minutes of rest. Normal vital sign ranges are listed below: 1. Systolic blood pressure: 90 - 140 mmHg 2. Diastolic blood pressure: 50 - 90 mmHg 3. Pulse rate: 45 - 100 beats per minute (bpm) 4. Oral body temperature: 35.0°C - 37.5°C 8. 12-lead electrocardiogram (ECG) is normal or considered not clinically significant by Investigator. 9. Participants must agree to not consume caffeine and/or xanthine containing products (i.e., coffee, tea, chocolate, caffeine-containing sodas, etc.), grapefruit and grapefruit containing products, and poppyseed containing foods within 48 hours prior to Period 1 check-in. 10. Able to comply with study procedures, in the opinion of the Investigator(s). 11. Willing to provide written consent for screening procedures. Legally authorized representatives will not be allowed to sign on behalf of participants in this trial.
Exclusion criteria
* To participate in this trial, volunteers must not meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0 to 360 minutes post dose | Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration) |
| Tmax | 0 to 360 minutes postdose | Time to reach maximum epinephrine plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 0 to 120 minutes postdose | PD |
| Diastolic Blood Pressure | 0 to 120 minutes postdose | PD |
| Pulse Rate | 0 to 120 minutes postdose | PD |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy Sweitzer
WashU Medical School
Outcome results
None listed