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

NCT06467201 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CE-24-02
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (4)

• Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs)

  Adverse events reported after dosing will be evaluated

  Upto Day 15 after dosing

• Number of participants with abnormal laboratory tests results

  Laboratory abnormalities after dosing will be evaluated

  Upto Day 15 after dosing

• Number of participants with abnormal vital signs

  Upto Day 15 after dosing

• Number of participants with abnormal Electrocardiogram readings

  Impact on QTc interval will be evaluated

  Upto Day 15 after dosing

Secondary Outcomes (4)

• Evaluate the Peak Plasma Concentration (Cmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126

  72 hours after dosing

• Evaluate the Area under the plasma concentration versus time curve (AUC) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126

  72 hours after dosing

• Evaluate the Time to maximum concentration (Tmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126

  72 hours after dosing

• Evaluate the half life (T1/2) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126

  72 hours after dosing

Study Arms (3)

KSHN001126 150mg

EXPERIMENTAL

Low Dose

Drug: KSHN001126 150mg

KSHN001126 300mg

EXPERIMENTAL

Mid Dose

Drug: KSHN001126 300mg

KSHN001126 600mg

EXPERIMENTAL

High Dose

Drug: KSHN001126 600mg

Interventions

KSHN001126 150mg DRUG

6 subjects will receive single oral dose of 150mg

KSHN001126 150mg

KSHN001126 300mg DRUG

6 subjects will receive single oral dose of 300mg

KSHN001126 300mg

KSHN001126 600mg DRUG

6 subjects will receive single oral dose of 600mg

KSHN001126 600mg

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures.
• Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination.
• Body Mass Index at screening between 18 and 30 kg/m2, inclusive.
• Post-menopausal females (Menopause is defined as the female is either 12 months off menstrual period after the age of 50 years, or 12 months off menstrual period after the age of 40 years and Follicle Stimulating Hormone (FSH) \> 40 mIU/mL. Amenorrhea should not be due to lactation).
• In good general health with no clinically significant illness seen on physical examination or ongoing medical history, as determined by the Investigator.
• Documented 12-lead ECG with no clinically significant abnormalities (with QTc interval between 360 to 440 msec), as determined by the Investigator in screening or Day 0.
• No clinically significant abnormalities in screening or Day 0 laboratory tests, as determined by the Investigator (Creatinine clearance should be ≥ 90 mL/min and Blood Urea Nitrogen / AST / ALT / Alkaline phosphatase / Total and direct bilirubin should be \< upper limit of normal).
• Female participants must have a negative serum pregnancy (β-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female participants must also be non-lactating.
• The participant is available to volunteer for the entire study duration and is willing to adhere to all protocol requirements.
• The participant has vital signs at screening, and at check-in within the following ranges:
• Blood Pressure:
• Systolic: (100- 140 mmHg
• Diastolic: (60-90) mmHg
• Body Temperature: (36.1 - 37.8) ºC, Pulse rate: 60 to 100 b/m. Respiratory rate: 12 to 20 bpm
• Participants with normal findings as determined by gynecological examination and USG Pelvis.

You may not qualify if:

• The participant is surgically induced postmenopausal female.
• Pregnant or lactating female participant.
• Any history of clinically significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the study results.
• History of allergy or major allergic reaction considered to be clinically significant by the Investigator.
• Receiving or has received any investigational drug within the 30 days before receiving KSHN001126.
• History or presence of low platelet count, bleeding issues or family history of bleeding disorders.
• Participant has a history of hypersensitivity to heparin as checked at screening.
• The participant has known allergy to the drug under investigation, or to any ingredient in the preparation
• The participant has an evidence of antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements.
• Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period.
• Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug.
• Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
• Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment.
• History of drug and/or alcohol dependence within past 12 months, and/or positive results on drug of abuse or alcohol tests.
• The participant is a smoker (smoker is defined as reporting tobacco use in the previous 3 months and/or has urine cotinine level equal or more than 500 ng/ml)

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead

Study Sites (2)

Advanced Pharma CR

Miami, Florida, 33147, United States

Location

Health1 Superspeciality Hospital

Ahmedabad, Gujarat, 380058, India

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 20, 2024
• Study Start: June 3, 2024
• Primary Completion: December 8, 2024
• Study Completion: March 12, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IN (1)