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

NCT06467201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2024-12-08
Completion
2025-03-12
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06467201 on ClinicalTrials.gov