drugset
drugset / Trial / NCT06467201

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

NCT06467201 ↗

Phase 1 Completed 18 enrolled Amneal Pharmaceuticals, LLC
Non-randomizedSequentialOpen-labelBasic science

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.

Timeline

Start
2024-06-03
Primary completion
2024-12-08
Completion
2025-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject KSHN001126 Unknown 150 mg Oral
Subject KSHN001126 Unknown 300 mg Oral
Subject KSHN001126 Unknown 600 mg Oral

Indications

No indication recorded.