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