Phase 1 Crossover Study Evaluating the Safety, Tolerability, and Pharmacokinetics of KP001 in Healthy Adult Volunteers

Launched by KOKUA PHARMA INC. · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KP001 to see how safe it is and how well it works compared to current treatments for severe allergic reactions, like anaphylaxis. The researchers want to find out if different doses of KP001 can be tolerated by healthy adults and if they work well in the body. Participants will take part in a series of doses, with follow-up visits to check on their health and how the treatment is processed by their bodies.

To join the study, you need to be a healthy adult between 18 and 45 years old, with a body weight of at least 45 kg for women and 50 kg for men. You should not smoke or have any major health issues. If you decide to participate, you'll spend a night in the research unit and then visit the clinic several times over two weeks for assessments after receiving the treatment. It's important to know that certain medical conditions and recent drug use may exclude you from participating, so make sure to check the eligibility criteria carefully.

Gender

ALL

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.