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

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

Timeline

Start

2025-05-09

Primary completion

2025-07-18

Completion

2025-07-18

Drugs

Indications