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

What this trial studies

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 in scope

• Healthy Postmenopausal Women

Interventions

• KSHN001126 150mg (Drug) — 6 subjects will receive single oral dose of 150mg
• KSHN001126 300mg (Drug) — 6 subjects will receive single oral dose of 300mg
• KSHN001126 600mg (Drug) — 6 subjects will receive single oral dose of 600mg

Who can join

Women only · Ages 45 Years to 60 Years · Accepts healthy volunteers.

Inclusion criteria

• 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.

Exclusion criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2024-06-03
• Primary completion: 2024-12-08
• Last update posted: 2026-02-19
• First posted: 2024-06-20

Sponsor & contact

Lead sponsor: Amneal Pharmaceuticals, LLC (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs) (Upto Day 15 after dosing)
  Adverse events reported after dosing will be evaluated
• Number of participants with abnormal laboratory tests results (Upto Day 15 after dosing)
  Laboratory abnormalities after dosing will be evaluated
• Number of participants with abnormal vital signs (Upto Day 15 after dosing)
• Number of participants with abnormal Electrocardiogram readings (Upto Day 15 after dosing)
  Impact on QTc interval will be evaluated

Related ClearedRx care

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