Evaluating a new inhaled treatment for allergic reactions in healthy adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Safety, Tolerability and Pharmacokinetics of Various Doses of KP001 (Epinephrine Inhalation Aerosol) in Healthy Adult Volunteers While Assessing Carryover Effects

This study is testing a new inhaled treatment for allergic reactions in healthy adults to see how safe it is and how well it works.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Kokua Pharma Inc. (other)
• Locations: 1 site (Quebec City, Quebec)
• Trial ID: NCT06963411 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, and pharmacokinetics of KP001, an inhaled treatment, in healthy adult volunteers. The study employs a 5-period crossover design where participants will receive different doses of KP001 or a placebo, with a washout period between doses. The trial will also explore the effects of breath-holding during inhalation to simulate conditions of unconscious patients. Participants will undergo multiple clinic visits for assessments over a total duration of up to 11 weeks.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 45 with a normal BMI and no significant medical history.

Not a fit: Patients with a history of significant medical conditions or those who smoke or use tobacco products will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective alternative to injected epinephrine for managing acute allergic reactions.

How similar studies have performed: While this approach is novel, similar studies evaluating inhaled treatments for allergic reactions have shown promise.

Eligibility criteria

Key Inclusion Criteria:

1. Males or females, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), aged ≥ 18 to ≤ 45 years.
2. A Body Mass Index (BMI) ≥18.5 and ≤ 30 kg/m\^2, with body weight, ≥ 50.0 kg for males and ≥ 45.0 kg for females.
3. Healthy as defined by a) the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration. b) the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
4. Normal lung function measured by spirometry.
5. Demonstrated ability to successfully complete pressurized metered dose inhaler (pMDI) training.
6. Demonstrated ability to successfully hold their breath for a minimum of 30 seconds.

Key Exclusion Criteria:

1. Positive urine drug screen, urine cotinine test, or alcohol breath test, at screening.
2. Known reaction or sensitivity to sympathomimetic amines, or idiosyncratic reaction to epinephrine or any of the ingredients of KP001, placebo.
3. History of anaphylaxis or other severe allergic reactions (e.g., angioedema)
4. Surgical procedures within 90 days of admission that could result in confounding of results or additional risk to the subject, per the judgment of the Investigator.
5. History or presence of alcohol abuse or drinking more than 2 standard drinks per day/10 standard drinks per week for women or 3 standard drinks per day/15 standard drinks per week for men; or a positive alcohol breath test at screening or admission.
6. History or presence of drug abuse/dependence (not including nicotine and caffeine) within the previous 1 year or a positive urine drug test at screening or admission.
7. Use of any tobacco or nicotine-containing products within 3 months prior to screening.
8. Use of any inhaled products, including vaping and water pipes (Hookahs) within 6 months prior to screening.
9. Use of any prescription medications within 14 days prior to admission, or over-the-counter medications (including herbal remedies and supplements) within 7 days prior to admission, with the exception of the occasional use of acetaminophen (up to 2 g daily), or an anticipated need to use them during the study.
10. A depot injection or implant of any drug (other than hormonal contraceptives) within 3 months prior to dosing.
11. Monoamine oxidase (MAO) inhibitors within 30 days prior to dosing.
12. Positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBsAg) at screening.
13. Abnormal clinical laboratory findings, vital signs, or ECG
14. Females who are pregnant or lactating, or who have a positive pregnancy test at screening or admission.
15. Donated plasma within 7 days prior to screening, or donation or loss of whole blood (excluding the volume drawn during screening for this study) as follows: 50 to 499 mL of whole blood within 30 days prior to screening, or ≥ 500 mL of whole blood within 56 days prior to screening.
16. Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 90 days prior to screening, or current/planned participation in another interventional study during this study.

Where this trial is running

Quebec City, Quebec

• Syneos HealthClinique Inc. — Quebec City, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Bruno Francoeur, MD — Syneos HealthClinique Inc.
• Study coordinator: Bruno Francoeur, MD

Conditions: Acute Allergic Reaction, Anaphylaxis, Epinephrine, Aerosol, Inhalation, Immunotherapy, Upper airway laryngeal edema, Upper airway pharyngeal edema