Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study

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®.

Timeline

Start

2023-03-01

Primary completion

2023-09-10

Completion

2023-10-01

Drugs

Indications