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NCT07210320 · ClinicalTrials.gov registry record · Phase 1
PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
A Phase 1 study of Food Allergy and Food Hypersensitivity, sponsored by Insignis Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07210320: Recruiting Phase 1 study of Food Allergy and Food Hypersensitivity, sponsored by Insignis Therapeutics.
NCT07210320 is a Phase 1 study of Food Allergy and Food Hypersensitivity that is actively recruiting participants, run by Insignis Therapeutics. The registered enrollment target is 30 participants, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07210320, a Phase 1 study of Food Allergy and Food Hypersensitivity, is actively recruiting participants, sponsored by Insignis Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, two-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray in healthy adults. For both 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) to help select the most appropriate dose/formulation to be used in Part 2 of the study in a larger number of participants (N=24).
Primary Outcome
Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Conditions Studied
Interventions
- DRUG Epinephrine Auto-Injector 0.3 mg/0.3 mL
- DRUG Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle
- DRUG IN-001 9.06 mg Sublingual Spray
- DRUG IN-001 13.59 mg Sublingual Spray
Study Locations (1)
Missouri
- Washington University in St. Louis School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What NCT07210320 shows while recruiting
NCT07210320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Food Allergy appearing as the primary indexed condition, and to 4 interventions - of which Epinephrine Auto-Injector 0.3 mg/0.3 mL is the first listed.
NCT07210320 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT07210320 about?
NCT07210320 is a clinical study titled "PK/PD Study of IN-001 Sublingual Spray in Healthy Adults". This is an open-label, two-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray in healthy adults. For both parts of the study, participants will undergo at least 10 hours of fasting prior to d...
What is the current status of trial NCT07210320?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-10-24. Estimated completion is 2026-03-31.
What conditions does trial NCT07210320 study?
This clinical trial studies the following conditions: Food Allergy, Food Hypersensitivity, Food Allergy Peanut, Anaphylaxis.
What interventions are being tested in trial NCT07210320?
The interventions under investigation include: Epinephrine Auto-Injector 0.3 mg/0.3 mL (DRUG), Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle (DRUG), IN-001 9.06 mg Sublingual Spray (DRUG), IN-001 13.59 mg Sublingual Spray (DRUG).
Who is sponsoring clinical trial NCT07210320?
This trial is sponsored by Insignis Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07210320 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07210320's enrollment target sits among peer trials
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