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PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
NCT07210320 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07210320
The ClinicalTrials.gov registry entry for NCT07210320 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insignis Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07210320 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07210320?
This trial is sponsored by Insignis Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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