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

NCT06074757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-10-10

No results posted yet for this study

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®.

Conditions

Interventions

DRUG

Fulvestrant injection

phosphate ester of fulvestrant for test arm

Sponsors & Collaborators

  • Kashiv BioSciences, LLC

    lead INDUSTRY

Principal Investigators

  • Dr Uday Harle, Phd medicine · Kashiv biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-09-10
Completion
2023-10-01

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06074757 on ClinicalTrials.gov