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

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).

Conditions

• Healthy Postmenopausal Women

Interventions

DRUG

KSHN001034

Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive low dose of KSHN001034 IM on Days 1, 8, 15, and 22.

DRUG

KSHN001034

Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive medium dose of KSHN001034 IM on Days 1, 8, 15, and 22.

DRUG

KSHN001034

Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive high dose of KSHN001034 IM on Days 1, 8, 15, and 22.

DRUG

KSHN001034

Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive low dose of KSHN001034 SC on Days 1, 8, 15, and 22.

DRUG

KSHN001034

Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive medium dose of KSHN001034 SC on Days 1, 8, 15, and 22.

DRUG

Fulvestrant

Reference Product: Faslodex® (Fulvestrant), 5 mL pre-filled syringe containing 250 mg/5 mL of fulvestrant, administered as two 5 mL injections (total 500 mg) via intramuscular (IM) injection. Marketed by AstraZeneca. • 2 subjects will receive 500 mg Fulvestrant IM on Days 1 and 15.

Sponsors & Collaborators

• Eric Solutions LLC

  collaborator UNKNOWN

• Clinexcel Research, Ahmedabad, India

  collaborator UNKNOWN

• Kashiv BioSciences, LLC

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-18

Primary Completion

2026-05-31

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States
• India

Study Locations