Acute Allergic ReactionPhase 1NCT06963411

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

A Phase 1 study testing KP001 in people with Acute Allergic Reaction and Anaphylaxis, run by Kokua Pharma Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Acute Allergic Reaction, Anaphylaxis
What is being tested?: KP001
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteCanada
Study dates: 9 May 2025to 18 Jul 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Syneos HealthClinique Inc.
Québec, Quebec, G1P 0A2

Other trials in Canada

About this study

Official title: 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

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

Read the 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 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

Conditions: Acute Allergic Reaction, Anaphylaxis
Being tested: KP001, Placebo
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
Medical subject headings: Anaphylaxis, Respiratory Aspiration, Hypersensitivity, Immediate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KP001Drug
Epinephrine Inhalation Aerosol (0.125 mg per inhalation)
PlaceboDrug
Matched Placebo control (KP001 vehicle only)

Study groups in NCT06963411
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: KP001; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 202518 Jul 2025

First posted9 May 2025
Study start9 May 2025
Primary completion18 Jul 2025
Study completion18 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Allergic ReactionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06963411
Sponsor's protocol ID: KP001-101
Status last verified: Aug 2025
First submitted: 24 Apr 2025
Last updated: 27 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All individual participant data collected during the trial, after deidentification