NCT07210320

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Insignis Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Epinephrine Auto-Injector 0.3 mg/0.3 mL	Epinephrine injection
DRUG	Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle	Epinephrine injection
DRUG	IN-001 9.06 mg Sublingual Spray	Sublingual Spray
DRUG	IN-001 13.59 mg Sublingual Spray	Sublingual Spray

Timeline

• Start date: 2025-10-24
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2025-10-07
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study