NCT06963411

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kokua Pharma Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
DRUG	KP001	Epinephrine Inhalation Aerosol (0.125 mg per inhalation)
DRUG	Placebo	Matched Placebo control (KP001 vehicle only)

Timeline

• Start date: 2025-05-09
• Primary completion: 2025-07-18
• Completion: 2025-07-18
• First posted: 2025-05-09
• Last updated: 2025-08-27

Locations

1 site across 1 country: Canada