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Food AllergyPhase 1NCT07210320

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

A Phase 1 study testing Epinephrine Auto-Injector 0.3 mg/0.3 mL, Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle and IN-001 9.06 mg Sublingual Spray in people with Food Allergy and Anaphylaxis, run by Insignis Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Food Allergy, Anaphylaxis, Food Hypersensitivity
What is being tested?
Epinephrine Auto-Injector 0.3 mg/0.3 mL, Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle and IN-001 9.06 mg Sublingual Spray
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
24 Oct 2025to 13 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • To participate in this trial, volunteers must meet all of the inclusion criteria listed below:
  • 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)
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  • 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:
  • Systolic blood pressure: 90 - 140 mmHg
  • Diastolic blood pressure: 50 - 90 mmHg
  • Pulse rate: 45 - 100 beats per minute (bpm)
  • Oral body temperature: 35.0°C - 37.5°C
  • 12-lead electrocardiogram (ECG) is normal or considered not clinically significant by Investigator.
  • 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.
  • Able to comply with study procedures, in the opinion of the Investigator(s).
  • Willing to provide written consent for screening procedures. Legally authorized representatives will not be allowed to sign on behalf of participants in this trial.

Who cannot join

  • To participate in this trial, volunteers must not meet any of the exclusion criteria listed below:
  • 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.
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  • Clinically significant history of alcoholism within the last 12 months, per Investigator's discretion. Participants must
  • 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
  • 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:
  • Ergot alkaloids
  • Cardiac glycosides
  • Diuretics
  • Anti-arrhythmic medications
  • Tricyclic antidepressants
  • Monoamine oxidase inhibitors
  • Levothyroxine sodium
  • Antihistamines, including chlorpheniramine and diphenhydramine
  • Tripelennamine
  • Propranolol
  • Phentolamine
  • Proton pump inhibitors
  • Antihypertensives
  • Chlorpromazine
  • Ethosuximide
  • Haloperidol
  • Lithium carbonate
  • Meperidine
  • Methenamine therapy
  • Norepinephrine
  • Phenobarbital
  • Phenytoin
  • Propoxyphene
  • Veratrum alkaloids
  • Any major illness in the last 3 months or any significant ongoing chronic medical illness as determined by the Investigator.
  • Presence or history of clinically significant disorders involving cardiovascular (e.g., cardiac arrhythmias, coronary artery or organic heart disease, or hypertension), respiratory, renal, hepatic, dermatologic, musculoskeletal, gastrointestinal, immunologic, hematologic, endocrine (e.g., hyperthyroidism, hypoglycemia, or diabetes) or neurologic systems (e.g., Parkinson's disease), or psychiatric disease (e.g., depression), as determined by the Investigator.
  • History of complaints of frequent dizziness or lightheadedness occurring more than once every week.
  • Existence of any surgical or medical condition which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or elimination of the study drug or is likely to compromise the safety of the participant.
  • Evidence of allergy or known hypersensitivity to epinephrine, sodium metabisulfite, or to any of the components of its formulation.
  • History or presence of difficult venipuncture for blood sampling.
  • History or presence of open sores or areas of irritation, redness, swelling, bleeding, lesions, piercings, or mucous membranes within the mouth.
  • Below normal serum pseudocholinesterase levels, defined as:
  • Males i. All ages: < 5,320 U/L b. Females i. Not taking hormonal contraceptives
  • <!-- -->
  • Ages 18-39 years: < 4,260 U/L
  • Ages > 40 years: < 5,320 U/L ii. Taking hormonal contraceptives
  • <!-- -->
  • Ages 18-41 years: < 3,650 U/L
  • Ages > 42 years: < 5,320 U/L
  • 20. Any blood donation, or excess blood loss, within 30 days prior to Period 1 dosing and throughout the duration of the study. Participant agrees to continue to abstain from blood donation, outside of study activities, through end of study.
  • 21. Any plasma donations or plans to donate plasma within 14 days prior to Period 1 dosing and throughout the duration of the study. Participant agrees to continue to abstain from plasma donation, outside of study activities, through end of study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University in St. Louis School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: An Open-label, Three-Part, Partially Randomized Single-Dose Crossover Study Evaluating the Safety, Tolerability, and Pharmacokinetics of L-dipivefrin (IN-001) Sublingual Solution Administered Via Spray Device or Oral Syringe in Comparison to Epinephrine 0.3 mg Manual Intramuscular Injection and Epinephrine 0.3 mg Auto-injection in Healthy Adult Volunteers Under Fasted Conditions

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.

Being tested
Epinephrine Auto-Injector 0.3 mg/0.3 mL, Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle, IN-001 9.06 mg Sublingual Spray, IN-001 13.59 mg Sublingual Spray
Keywords
Type 1 allergy, epinephrine, anaphylaxis, food allergy
Medical subject headings
Food Hypersensitivity, Anaphylaxis, Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epinephrine Auto-Injector 0.3 mg/0.3 mLDrug

    Also called Epipen

    Epinephrine injection

  • Epinephrine 0.3 mg intramuscular manual injection via a syringe and needleDrug

    Also called Adrenalin

    Epinephrine injection

  • IN-001 9.06 mg Sublingual SprayDrug

    Also called IN-001

    Sublingual Spray

  • IN-001 13.59 mg Sublingual SprayDrug

    Also called IN-001

    Sublingual Spray

Study groups in NCT07210320
Study groupRoleWhat they receive
Treatment Period 1Active comparatorEpiPen 0.3 mg
Receives: Drug: Epinephrine Auto-Injector 0.3 mg/0.3 mL
Treatment Period 2Active comparatorEpinephrine 0.3 mg IM
Receives: Drug: Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle
Treatment Period 3ExperimentalIN-001 Sublingual Spray
Receives: Drug: IN-001 9.06 mg Sublingual Spray
Treatment Period 4ExperimentalIN-001 Sublingual Spray
Receives: Drug: IN-001 13.59 mg Sublingual Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

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

    Measured: 0 to 360 minutes post dose

  2. Tmax

    Time to reach maximum epinephrine plasma concentration

    Measured: 0 to 360 minutes postdose

Secondary outcomes (3)

  1. Systolic Blood Pressure

    PD

    Measured: 0 to 120 minutes postdose

  2. Diastolic Blood Pressure

    PD

    Measured: 0 to 120 minutes postdose

  3. Pulse Rate

    PD

    Measured: 0 to 120 minutes postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2025
  2. Study start24 Oct 2025
  3. Primary completion12 Apr 2026
  4. Study completion13 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07210320
Sponsor's protocol ID
ITI-25-001
Status last verified
May 2026
First submitted
29 Sep 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epinephrine Auto-Injector 0.3 mg/0.3 mL, Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle and IN-001 9.06 mg Sublingual Spray in people with Food Allergy and Anaphylaxis, run by Insignis Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: 0 to 360 minutes post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07210320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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