NCT06467201

SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females

An Open-label, Sequential Dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Human Post-Menopausal Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Postmenopausal Women

Interventions

Type	Name	Description
DRUG	KSHN001126 150mg	6 subjects will receive single oral dose of 150mg
DRUG	KSHN001126 300mg	6 subjects will receive single oral dose of 300mg
DRUG	KSHN001126 600mg	6 subjects will receive single oral dose of 600mg

Timeline

• Start date: 2024-06-03
• Primary completion: 2024-12-08
• Completion: 2025-03-12
• First posted: 2024-06-20
• Last updated: 2026-02-19

Locations

2 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study