Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study
Status:
Completed
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn the comparative pharmacokinetic parameters
between the test product and the Reference listed drug in healthy female volunteers
The main question[s] it aims to answer are:
- To assess the sequential dose exposure safety and tolerability of KSHN001034 injection
in healthy female subjects after single ascending doses from 25 mg to 500 mg and
multiple doses of maximum tolerable dose from single ascending dose
- To assess dose showing comparative bioavailability of KSHN001034 injection in comparison
with Faslodex®.