IN-001 Sublingual Spray for Anaphylaxis

Overseen By Kaitlin Moore

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Insignis Therapeutics, Inc.

Must not be taking: Antidepressants, Antihypertensives, Antihistamines, others

Disqualifiers: Pregnancy, HIV, Hepatitis, Alcoholism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sublingual spray (placed under the tongue) for delivering epinephrine, a treatment commonly used for severe allergic reactions. The study aims to understand how the body absorbs and reacts to this new spray compared to other forms of epinephrine. Researchers seek healthy adults who haven’t had major illnesses recently and can avoid certain medications and products like caffeine and grapefruit. Participants will help determine the best dose for future studies. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new form of epinephrine.

Will I have to stop taking my current medications?

Yes, you will need to stop taking most prescription and over-the-counter medications before joining the trial. There are specific medications listed that you must not use within certain time frames before the study starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the IN-001 sublingual spray, containing epinephrine, is safe and generally well-tolerated. In earlier studies, side effects were mild, brief, and resolved on their own. This spray offers a needle-free method to deliver epinephrine, commonly used for severe allergic reactions. The aim is to simplify and enhance the reliability of emergency treatment. These results are encouraging for potential trial participants, suggesting the treatment is generally safe based on previous human testing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for anaphylaxis, which typically involves injectable epinephrine, the IN-001 sublingual spray offers a unique and potentially more convenient delivery method. This spray is designed to be administered under the tongue, providing a quick and easy way to treat severe allergic reactions without the need for needles. Researchers are excited about this innovation because it could simplify treatment, making it more accessible and less intimidating for patients who might hesitate to use an injection. Plus, the rapid absorption under the tongue could offer swift relief, which is crucial in emergencies.

What evidence suggests that the IN-001 sublingual spray could be an effective treatment for anaphylaxis?

Studies have shown that the IN-001 sublingual spray, one of the treatments tested in this trial, can safely and effectively deliver epinephrine without needles. Research indicates that it quickly reaches necessary levels in the body and maintains them for up to two hours, making it a reliable option for treating anaphylaxis, a severe allergic reaction. Initial findings suggest that the spray is well-tolerated, with mild side effects that resolve on their own. While still under investigation in this trial, these results are promising for those seeking a needle-free method to manage anaphylactic reactions. ^{1 2 4 5 6}

Who Is on the Research Team?

Nancy Sweitzer

Principal Investigator

WashU Medical School

Are You a Good Fit for This Trial?

This trial is for healthy adults who can fast for at least 10 hours before dosing. Specific eligibility details are not provided, but typically participants should not have conditions that could interfere with the study or pose a risk to their health.

Inclusion Criteria

Physical examination must be normal

Women of childbearing potential or men with childbearing potential partners must agree to use effective birth control methods

I am between 18 and 45 years old.

Exclusion Criteria

History of clinically significant alcoholism within the last 12 months

History of addiction, abuse, and misuse of any drug

Use of tobacco/nicotine containing products within the last 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Part 1

Participants receive single doses of test and reference products across four treatment periods with washout periods in between.

2 weeks

4 visits (in-person)

Treatment Part 2

Participants are randomized to receive single doses of selected study products across three treatment periods with washout periods in between.

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 24-hour post-dose follow-up phone call.

1 week

1 phone call

What Are the Treatments Tested in This Trial?

Interventions

• Epinephrine
• IN-001 Sublingual Spray

Trial Overview The study tests how IN-001 Sublingual Spray (a form of epinephrine) works and behaves in the body compared to standard epinephrine injections. It's an open-label study with two parts: initial dose exploration followed by testing on more people.

How Is the Trial Designed?

Group I: Treatment Period 4 Experimental Treatment 1 Intervention

IN-001 Sublingual Spray

Group II: Treatment Period 3 Experimental Treatment 1 Intervention

IN-001 Sublingual Spray

Group III: Treatment Period 1 Active Control 1 Intervention

EpiPen 0.3 mg

Group IV: Treatment Period 2 Active Control 1 Intervention

Epinephrine 0.3 mg IM

Who Is Running the Clinical Trial?

Insignis Therapeutics, Inc.

Lead Sponsor

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Citations

1. insignisrx.com insignisrx.com/insignis-therapeutics-announces-positive-results-from-phase-1-clinical-study-of-in-001-liquid-epinephrine-sublingual-spray-for-anaphylaxis/

Insignis Therapeutics Announces Positive Results from ... “The results of the A24-1889 study provide compelling evidence that IN-001 could be a safer and more reliable needle-free option for epinephrine ...

2. synapse.patsnap.com synapse.patsnap.com/article/insignis-therapeutics-reports-positive-phase-1-results-for-in-001-epinephrine-spray

Insignis Therapeutics Reports Positive Phase 1 Results for ... IN-001 was deemed safe and well-tolerated, with all adverse events being mild, transient, and self-resolving, requiring no intervention. The ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07210320

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 ...

4. hcplive.com hcplive.com/view/epinephrine-nasal-spray-effective-as-injection-anaphylaxis-real-world-data

Epinephrine Nasal Spray as Effective as Injection for ... Epinephrine nasal spray shows comparable effectiveness to injections for anaphylaxis, with a success rate of 89.2% in real-world settings. The ...

5. globenewswire.com globenewswire.com/news-release/2024/10/07/2958883/0/en/Insignis-Therapeutics-Announces-Positive-Results-from-Phase-1-Clinical-Study-of-IN-001-Liquid-Epinephrine-Sublingual-Spray-for-Anaphylaxis.html

Insignis Therapeutics Announces Positive Results from ... Insignis' Phase 1 trial shows IN-001 spray quickly reaches target epinephrine levels, sustained for 2 hours, offering a reliable needle-free ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37279803/

Innovations in the Treatment of Anaphylaxis: A Review ... This review explores innovative nasal and oral products under investigation for the outpatient emergency treatment of anaphylaxis.