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Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers

A Phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) Study Evaluating the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers

NCT06995482•Kashiv BioSciences, LLC

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate if KSHN001034 demonstrates safety, tolerability, and a comparable pharmacokinetic (PK) profile to the reference product, Faslodex® (fulvestrant), which is used for the treatment of hormone receptor-positive breast cancer. Participants will: Receive either the test product (KSHN001034) or the reference product (Faslodex®) administered intramuscularly (IM) or subcutaneously (SC) at doses of low, medium, or high , with doses conducted in 5 cohorts and these participants will be healthy postmenopausal female volunteers. Dosing will be administered in a sequential cohort-wise manner across five cohorts, with DSMB oversight for safety monitoring and dose escalation. Primary Endpoint: Safety and tolerability will be assessed based on the occurrence, severity, and relationship of adverse events (AEs), including serious adverse events (SAEs). Secondary Endpoint: Pharmacokinetic (PK) parameters will be evaluated, including Cmax (maximum concentration), Tmax (time to maximum concentration), AUC (area under the curve), and T1/2 (half-life).

Detailed Description

A phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of KSHN001034 in comparison with US-licensed Faslodex® (Fulvestrant) administered through intramuscular (IM) and subcutaneous (SC) routes in healthy postmenopausal female volunteers. Participants will be randomized in a 3:1 ratio to receive either KSHN001034 (administered IM or SC at low, medium, or high dose in five cohorts) or the reference product, Faslodex® (500 mg IM). Dose escalation will proceed cohort-wise, based on DSMB review of cumulative safety and PK data. PK blood samples will be collected from Day 1 to Day 36 across multiple pre- and post-dose timepoints to estimate PK parameters. Safety assessments include adverse events (AEs), serious adverse events (SAEs) as assessed by CTCAE v5.0.

Eligibility

Age

45 - 60 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures.
•2. Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination.
•3. Body Mass Index at screening between 18 and 30 kg/m2, inclusive.
•4. 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 45 years and FSH \> 40 mIU/mL Note: Amenorrhea should not be due to lactation).
•5. Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead Electrocardiogram (ECG) performed during screening and as determined by the Principal Investigator (PI).
•6. Hemoglobin at screening and Day (-1) ≥ 11 g/dl
•7. Ability to communicate well and to comply with the requirements of the entire study.
•8. Adequate venous access and can able to give required blood samples.

Exclusion Criteria

•1. History or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease or any other clinical significant abnormalities during screening investigations which, in the opinion of the PI, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
•2. Evidence of organ dysfunction \[e.g. liver dysfunction; ≥ Upper Limit of Normal (ULN) for ALT, AST or ALP or renal dysfunction (\<90 mL/min of creatinine clearance by Cockroft-Gault formula\] or any clinically significant abnormalities in other clinical laboratory parameters at screening as determined by the investigator.
•3. QTc (Bazzett) interval ≥450 ms on ECG at screening.
•4. Any major surgery requiring general anesthesia within 3 months prior to screening.
•5. Known or suspected history of alcohol dependency or addictive substance use, as judged by the investigator Note: Participants will be required to abstain from recreational use of soft addictive substances (such as marijuana) within 2 weeks or hard addictive substances (such as cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives) within 2 months prior to screening
•6. History or presence of malignancy in the last 5 years
•7. Positive testing for human immunodeficiency virus (HIV I or II), hepatitis B (hepatitis B surface antigen \[HBsAg\]), or hepatitis C (Anti-HCV antibody) at screening.
•8. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
•9. Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period.
•10. Presence of low platelet count (i.e. lower than LLN), bleeding issues or family history of bleeding disorders.
+11 more criteria

Locations (2)

Floridian Clinical Research LLC

Miami Lakes, Florida, United States

Synergen Bio Pvt. Ltd.

Pune, Maharashtra, India

Key Dates

Start Date

August 18, 2025

Primary Completion Date

May 1, 2026

Completion Date

June 1, 2026

Last Updated

February 12, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Postmenopausal Women

Interventions

KSHN001034

DRUG

KSHN001034

DRUG

KSHN001034

DRUG

KSHN001034

DRUG

KSHN001034

DRUG

Fulvestrant

DRUG

Contacts

Pawan Singh

CONTACT

+91 7666522355 pawan.singh@kashivindia.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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