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Clinical trialNCT07210320CompletedPhase 1Interventional

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

SponsorInsignis Therapeutics, Inc.Enrollment32AnaphylaxisFood AllergyFood Allergy PeanutFood Hypersensitivity
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Washington University in St. Louis School of Medicine

    St Louis, Missouri, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Epinephrine 0.3 mg intramuscular manual injection via a syringe and needleEpinephrine Auto-Injector 0.3 mg/0.3 mLIN-001 13.59 mg Sublingual SprayIN-001 9.06 mg Sublingual Spray
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
24 Oct 2025
Primary completion
12 Apr 2026
Completion
13 Apr 2026
Last update posted
5 May 2026
Registered enrollment
32
Registry id
NCT07210320
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.