NCT06074757

Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study

Open Label Sequential Dosing Single Ascending Dose of Four Cohort and Multiple Dose of One Cohort Pharmacokinetics Tolerability and Safety of Fulvestrant Injection as Test Product KSHN001034 vs Reference Product FASLODEX®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Kashiv BioSciences, LLC · Industry
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn the comparative pharmacokinetic parameters between the test product and the Reference listed drug in healthy female volunteers The main question\[s\] it aims to answer are: * To assess the sequential dose exposure safety and tolerability of KSHN001034 injection in healthy female subjects after single ascending doses from 25 mg to 500 mg and multiple doses of maximum tolerable dose from single ascending dose * To assess dose showing comparative bioavailability of KSHN001034 injection in comparison with Faslodex®.

Detailed description

Single ascending dose (SAD) of four cohorts (01, 02, 03, and 04) for the test product (25, 100, 250, and 500 mg, respectively). Subjects who will participate in cohort no. 01 (N= 18 subjects) will be randomized to receive a single dose of the test product 25 mg (N= 10 subjects) or a single dose of the reference product 500 mg (N= 08 subjects). The randomization ratio will be 5:4 for T: R Study Part II: Multiple doses of three treatment arms will be administered in one cohort (N= 32, parallel design). • Two treatment arms of the test product: T1: the dose lower than maximum tolerated dose (MTD-1) determined in Study Part I, N=12 subjects. T2: maximum tolerated dose determined in Study Part I, N=12 subjects. • One treatment arm of the reference product: R: 500 mg, N= 08 subjects The randomization ratio will be 3:3:2 for T1:T2: R\]

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant injection	phosphate ester of fulvestrant for test arm

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-09-10
• Completion: 2023-10-01
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: Jordan