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

Conditions

• Healthy Postmenopausal Women

Eligibility Criteria

Sex

FEMALE

Age

45 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• KSHN001034 — DRUG
  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.
• KSHN001034 — DRUG
  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.
• KSHN001034 — DRUG
  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.
• KSHN001034 — DRUG
  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.
• KSHN001034 — DRUG
  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.
• Fulvestrant — DRUG
  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.

Study Details

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).

Key Dates

Start date

Aug 18, 2025

Status verified

Feb 2026

Primary completion

May 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Cohort 1
• Experimental: Cohort 2
• Experimental: Cohort 3
• Experimental: Cohort 4
• Experimental: Cohort 5

Primary Outcome Measure

Number of participants with treatment-related Adverse events as assessed by CTCAE v5.0 [ Time Frame: up to 36 days after dosing ]

Central Contacts

• Pawan Singh
  +91 7666522355
  [email protected]

Locations (1)

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