Phase 1 Crossover Study Evaluating the Safety, Tolerability, and Pharmacokinetics of KP001 in Healthy Adult Volunteers
Status:
COMPLETED
Trial end date:
2025-07-18
Target enrollment:
Participant gender:
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