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

NCT07210320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • Insignis Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nancy Sweitzer · WashU Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2026-04-12
Completion
2026-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07210320 on ClinicalTrials.gov