PK/PD Study of IN-001 Sublingual Spray in Healthy Adults

NCT07210320 | Completed Phase 1 FDA Drug

• 1 other identifier: ITI-25-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Anaphylaxis; Food Hypersensitivity; Food Allergy Peanut

Keywords

Type 1 allergy, epinephrine, anaphylaxis, food allergy

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)

  0 to 360 minutes post dose

• Tmax

  Time to reach maximum epinephrine plasma concentration

  0 to 360 minutes postdose

Secondary Outcomes (3)

• Systolic Blood Pressure

  0 to 120 minutes postdose

• Diastolic Blood Pressure

  0 to 120 minutes postdose

• Pulse Rate

  0 to 120 minutes postdose

Study Arms (4)

Treatment Period 1

ACTIVE COMPARATOR

EpiPen 0.3 mg

Drug: Epinephrine Auto-Injector 0.3 mg/0.3 mL

Treatment Period 2

ACTIVE COMPARATOR

Epinephrine 0.3 mg IM

Drug: Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle

Treatment Period 3

EXPERIMENTAL

IN-001 Sublingual Spray

Drug: IN-001 9.06 mg Sublingual Spray

Treatment Period 4

EXPERIMENTAL

IN-001 Sublingual Spray

Drug: IN-001 13.59 mg Sublingual Spray

Interventions

Epinephrine Auto-Injector 0.3 mg/0.3 mL DRUG

Epinephrine injection

Also known as: Epipen

Treatment Period 1

Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle DRUG

Epinephrine injection

Also known as: Adrenalin

Treatment Period 2

IN-001 9.06 mg Sublingual Spray DRUG

Sublingual Spray

Also known as: IN-001

Treatment Period 3

IN-001 13.59 mg Sublingual Spray DRUG

Sublingual Spray

Also known as: IN-001

Treatment Period 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 years of age and \< 45 years of age.
• 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:
• Abstinence
• Hormonal contraceptives for at least one month prior to Screening
• Double barrier (e.g., diaphragm with spermicide, condom with spermicide)
• Intrauterine device (IUD)
• 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.
• BMI \> 18.50 and \< 29.90 kg/m2 (using formula BMI = weight (kg)/height (m2).
• All clinical laboratory test results (e.g., hematology, chemistry, urinalysis) are within normal limits or considered not clinically significant by Investigator.
• Serum pseudocholinesterase activity is within normal limits or considered not clinically significant by Investigator.
• Physical examination (excluding genital and rectal exams) is normal or considered not clinically significant by Investigator.
• 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:

You may not qualify if:

• Resident of a care facility, incarcerated individual, or individual in residential treatment facilities.
• Pregnant and/or breastfeeding.
• Females of childbearing potential should have a negative pregnancy test.
• Females must agree to refrain from breastfeeding from screening visit through 14 days after the last dose of study drug.
• Known history of Human Immunodeficiency Virus (HIV) 1 \& 2 and hepatitis B \& C virus.
• Clinically significant history of alcoholism within the last 12 months, per Investigator's discretion. Participants must
• a. have a negative breath alcohol test at screening. b. agree to abstain from using alcohol for 7 days prior to dosing in Period 1 until the end of study.
• Clinically significant history of addiction, abuse, and misuse of any drug, per the Investigator's discretion. Participants must
• a. have a negative drug test for substances of abuse at screening. b. agree to abstain from using drugs for 7 days prior to dosing in Period 1 until the end of study.
• Use of tobacco/nicotine containing products (e.g., chewing tobacco, smoking cigarettes, and/or electronic cigarettes) within the last 12 months. Participants must agree to abstain from using tobacco/nicotine containing products from the screening visit until the end of study.
• Use of or planned use of any investigational products (i.e., dosing in any clinical investigation) within 30 days prior to Period 1 dosing or within 10 half-lives of the investigational agent previously taken (whichever is longer).
• Use of or planned use of any prescription medications, except hormonal contraceptives, within 14 days prior to Period 1 dosing.
• Use of or planned use of any over-the-counter medications (e.g., aspirin, ibuprofen, antacids, etc.) within 5 days prior to Period 1 dosing.
• Use of or planned use of hormone replacement therapy within 90 days prior to Period 1 dosing.
• Use of or planned use of any of the following medications within 30 days prior to Period 1 dosing:

Sponsors & Collaborators

• Insignis Therapeutics, Inc.: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity; Anaphylaxis; Peanut Hypersensitivity

Interventions

Epinephrine; Needles

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Equipment and Supplies

Study Officials

• Nancy Sweitzer

  WashU Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: October 24, 2025
• Primary Completion: April 12, 2026
• Study Completion: April 13, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)