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

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.

NCT Number	NCT07210320
Lead Sponsor	Insignis Therapeutics, Inc. Collaborators: Washington University School of Medicine
Conditions	Food Allergy, Anaphylaxis, Food Hypersensitivity, Food Allergy Peanut
Enrollment	32 participants
Start Date	2025-10-24
Primary Completion	2026-04-12 (estimated)
Study Completion	2026-04-13 (estimated)
Updated on ClinicalTrials.gov	2026-05-05