NCT06995482

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kashiv BioSciences, LLC · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Postmenopausal Women

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-18
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-05-29
• Last updated: 2026-02-12

Locations

2 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study