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

NCT06963411 | Completed Phase 1

• 1 other identifier: KP001-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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

Conditions

Acute Allergic Reaction; Anaphylaxis

Keywords

Epinephrine; Aerosol; Inhalation; Immunotherapy; Upper airway laryngeal edema; Upper airway pharyngeal edema; Hypersensitivity, immediate; Anaphylaxis; Vasoconstrictor agents; Adrenergic alpha-Agonists; Adrenergic beta-Agonists; Bronchodilator agents

Outcome Measures

Primary Outcomes (6)

• The maximal observed plasma concentration (Cmax)

  Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.

  1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29

• Area under the concentration-time curve from time zero to last measurable concentration (AUC0-t)

  Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.

  1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29

• Area under the concentration-time curve from time zero to infinity (AUC0-inf)

  Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.

  1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29

• Time when the maximal plasma concentration is observed (Tmax)

  Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.

  1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29

• Rate at which drug is removed from the body (Kel)

  Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.

  1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29

• Half-life of drug (T1/2)

  Blood samples for PK collected at pre dose (-60, -30, -15 mins prior to dosing) and 1, 2, 3, 5, 7, 9, 12, 15, 20, 30, 45, 60, 90 min postdose and, 2-, 6 hours post-dose.

  1 hour pre-dose to 6 hours post-dose on Day 1, 8, 15, 22 and 29

Study Arms (3)

Treatment Arm A: Two Treatments

EXPERIMENTAL

Subjects will receive two sets of treatments of 0.25 mg (2 inhalations of 0.125 mg each time) of KP001 (or matching placebo) over 2 visits separated by a 1-week washout period. Investigational Product (IP) will be delivered as 1 set of 2 inhalations (2 total) spaced approximately 10 seconds apart. Subjects will repeat Arm therefore total dose in mg for Arm = 0.5 mg.

Drug: KP001; Drug: Placebo

Treatment Arm B: Four Treatments

EXPERIMENTAL

Subjects will receive four sets of treatments of 0.25 mg (2 inhalations of 0.125 mg each time), totaling 1.0mg of KP001 (or matching placebo) over 2 visits separated by a 1-week washout period. IP will be delivered as 4 sets of 2 inhalations (8 total) spaced approximately 10 seconds apart. Each set of 2 inhalations will be spaced approximately 2 minutes apart. Subjects will repeat Arm therefore total dose in mg for Arm = 2.0 mg.

Drug: KP001; Drug: Placebo

Treatment Arm C: Breath Hold

EXPERIMENTAL

Subjects will receive 0.5 mg of KP001 (or matching placebo) delivered as 4 rapidly administered sequential inhalations (4 total), dosed approximately 5 seconds apart, spaced over approximately 15 seconds while holding their breath during the entire dosing treatment and after treatment for a total minimum 30 seconds (or longer) before exhaling. Total dose in mg for Arm = 0.5 mg.

Drug: KP001; Drug: Placebo

Interventions

KP001 DRUG

Epinephrine Inhalation Aerosol (0.125 mg per inhalation)

Treatment Arm A: Two Treatments; Treatment Arm B: Four Treatments; Treatment Arm C: Breath Hold

Placebo DRUG

Matched Placebo control (KP001 vehicle only)

Treatment Arm A: Two Treatments; Treatment Arm B: Four Treatments; Treatment Arm C: Breath Hold

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kokua Pharma Inc.: lead

Study Sites (1)

Syneos HealthClinique Inc.

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Conditions

Anaphylaxis; Respiratory Aspiration; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno Francoeur, MD

  Syneos HealthClinique Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The order of the treatment arms A and B will be randomized, all subjects will proceed to Arm C once Arms A and B are completed. Subjects will receive the same treatment they were assigned to in all 3 arms (either KP001 or placebo). There will be a 7-day washout period between the repeated doses of Arms A and/or B, and a subsequent 7-day washout period, once both Arms are completed, when all subjects will be assigned to Arm C. Sequences will be AABBC or BBAAC and carried out as follows: AABBC - Treatment A/ 7 day washout/ Repeat Treatment A/ 7 day washout/ Treatment B / 7 day washout/ Repeat Treatment B/ 7 day washout/ Treatment C OR BBAAC - Treatment B/ 7 day washout/ Repeat Treatment B/ 7 day washout/ Treatment A/ 7 day washout/ Repeat Treatment A/ 7 day washout/ Treatment C.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 9, 2025
• Study Start: May 9, 2025
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Immediately after publication, and for a period of 5 years.
• Access Criteria: Any purpose. URL to be added.

Locations

CA (1)