CompletedPhase 1

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

Canada16 participantsStarted 2025-05-09

Plain-language 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

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The maximal observed plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

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

Half-life of drug (T1/2)

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

Trial details

NCT IDNCT06963411

SponsorKokua Pharma Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-18

View on ClinicalTrials.gov More Acute Allergic Reaction trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

What they're measuring

The maximal observed plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

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

Half-life of drug (T1/2)

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria