Overview

SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of KSHN001126 in Healthy Post-Menopausal Females

Status:
NOT_YET_RECRUITING

Trial end date:
2025-03-01

Target enrollment:

Participant gender:

Summary

This is an Open-label, Sequential dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of KSHN001126 in Healthy Human Post-Menopausal Female Volunteers. The primary objective of the study is to evaluate the safety and tolerability of increasing single doses of KSHN001126 while the secondary objective is to evaluate the plasma PK profile of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126.

Phase:

PHASE1

Details

Lead Sponsor:

Shivanka Research, LLC

Collaborators:

Clinexcel Research, Ahmedabad, India
Eric Solutions LLC