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Clinical trial

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

NCT07210320 is registered in ClinicalTrials.gov with Insignis Therapeutics, Inc. as lead sponsor.

NCT NCT07210320
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Insignis Therapeutics, Inc.
Phase
Phase 1
Overall status
Completed
Start date
October 24, 2025
Completion date
April 13, 2026
Enrollment
32 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

anaphylaxis, food allergy, food allergy peanut, food hypersensitivity