Status:
COMPLETED
Phase 1 Crossover Study Evaluating the Safety, Tolerability, and Pharmacokinetics of KP001 in Healthy Adult Volunteers
Lead Sponsor:
Kokua Pharma Inc.
Conditions:
Acute Allergic Reaction
Anaphylaxis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of several KP001 dose regimens to identify a treatment regimen with a PK profile that safely meets or...
Detailed Description
This study is a 5-period crossover design to evaluate the safety, tolerability, and PK of KP001 compared to placebo and to evaluate for the potential for carryover effect (Arms A \& B). An exploratory...
Eligibility Criteria
Inclusion
- Key
- Males or females, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), aged ≥ 18 to ≤ 45 years.
- 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.
- 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.
- Normal lung function measured by spirometry.
- Demonstrated ability to successfully complete pressurized metered dose inhaler (pMDI) training.
- Demonstrated ability to successfully hold their breath for a minimum of 30 seconds.
- Key
Exclusion
- Positive urine drug screen, urine cotinine test, or alcohol breath test, at screening.
- Known reaction or sensitivity to sympathomimetic amines, or idiosyncratic reaction to epinephrine or any of the ingredients of KP001, placebo.
- History of anaphylaxis or other severe allergic reactions (e.g., angioedema)
- 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.
- 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.
- 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.
- Use of any tobacco or nicotine-containing products within 3 months prior to screening.
- Use of any inhaled products, including vaping and water pipes (Hookahs) within 6 months prior to screening.
- 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.
- A depot injection or implant of any drug (other than hormonal contraceptives) within 3 months prior to dosing.
- Monoamine oxidase (MAO) inhibitors within 30 days prior to dosing.
- Positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBsAg) at screening.
- Abnormal clinical laboratory findings, vital signs, or ECG
- Females who are pregnant or lactating, or who have a positive pregnancy test at screening or admission.
- 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.
- 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.
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06963411
Start Date
May 9 2025
End Date
July 18 2025
Last Update
August 27 2025
Active Locations (1)
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1
Syneos HealthClinique Inc.
Québec, Quebec, Canada, G1P 0A2