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

Last updated: May 14, 2025
Sponsor: Kokua Pharma Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Allergy

Allergies & Asthma

Allergy (Pediatric)

Treatment

Placebo

KP001

Clinical Study ID

NCT06963411
KP001-101
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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 exceeds the PK profile of existing injected epinephrine products. The main questions it aims to answer are:

  • To evaluate any carryover effect with a 7-day washout of different dose regimens of KP001 in healthy adult volunteers.

  • To evaluate the safety, tolerability and PK of different dose regimens of KP001 in healthy adult volunteers.

  • To explore the safety, tolerability and PK of one KP001 dose regimen without inhalation (breath holding).

Participants will:

  • Be admitted to clinical research unit (Day -1) and receive treatment the following day (Day 1) and then will be discharged

  • Visit the clinic on Days 2 & 3 post dose for required assessments

  • Visit the clinic 6 days post their last dose for dosing and repeated until 5 dosing visits have been completed

  • Visit the clinic for a safety follow-up visit approximately 1 week from last dose administered

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Males or females, non-smoker (no use of tobacco or nicotine products within 3 monthsprior 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 malesand ≥ 45.0 kg for females.

  3. Healthy as defined by a) the absence of clinically significant illness and surgerywithin 4 weeks prior to study drug administration. b) the absence of clinicallysignificant history of neurological, endocrine, cardiovascular, respiratory,hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, andmetabolic 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.

Exclusion

Key Exclusion Criteria:

  1. Positive urine drug screen, urine cotinine test, or alcohol breath test, atscreening.

  2. Known reaction or sensitivity to sympathomimetic amines, or idiosyncratic reactionto 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 ofresults 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 perday/10 standard drinks per week for women or 3 standard drinks per day/15 standarddrinks per week for men; or a positive alcohol breath test at screening oradmission.

  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 toscreening.

  8. Use of any inhaled products, including vaping and water pipes (Hookahs) within 6months prior to screening.

  9. Use of any prescription medications within 14 days prior to admission, orover-the-counter medications (including herbal remedies and supplements) within 7days 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), orhepatitis 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 atscreening 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 499mL of whole blood within 30 days prior to screening, or ≥ 500 mL of whole bloodwithin 56 days prior to screening.

  16. Participation in another clinical study involving an investigational drug within 30days prior to screening, an investigational biologic within 90 days prior toscreening, or current/planned participation in another interventional study duringthis study.

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 01, 2025
Estimated Completion Date:
July 31, 2025

Study 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 3rd arm (Arm C) will evaluate the PK of KP001 when breath holding to replicate an unconscious patient situation, and results will be used to design a possible future breath-holding study. Sequence will be either AABBC or BBAAC. Two doses of KP001 (0.25 mg or 1.0 mg) or placebo will be administered to 16 subjects (12 active and 4 placebo subjects) on two separate occasions, separated by a 1-week washout period. A third arm will evaluate one dose of KP001 (0.5 mg) PK while breath holding.

The total study duration for subjects will be up to 11 weeks, consisting of:

  • Participation in up to 6-week screening period

  • Attendance of 5 in-patient dosing visits, separated by 1 week

  • Attendance of 1-week post-treatment follow up period

Connect with a study center

  • Syneos HealthClinique Inc.

    Quebec City, Quebec G1P 0A2
    Canada

    Active - Recruiting

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