KSHN001034 for Healthy Postmenopausal Women

Recruiting at 1 trial location

Overseen By Pawan Singh

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Kashiv BioSciences, LLC

Must not be taking: Prescribed medications

Disqualifiers: Cardiovascular, Pulmonary, Hepatic, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 36 days

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for healthy postmenopausal women. It's designed to test the safety and how the body processes a new drug, KSHN001034, compared to an existing breast cancer treatment, Faslodex.

Inclusion Criteria

Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures

Body Mass Index at screening between 18 and 30 kg/m2, inclusive

Hemoglobin at screening and Day (-1) ≥ 11 g/dl

Exclusion Criteria

Presence of low platelet count (i.e. lower than LLN), bleeding issues or family history of bleeding disorders

QTc (Bazzett) interval ≥450 ms on ECG at screening

Positive testing for human immunodeficiency virus (HIV I or II), hepatitis B (hepatitis B surface antigen [HBsAg]), or hepatitis C (Anti-HCV antibody) at screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either KSHN001034 or Faslodex® administered intramuscularly or subcutaneously in a sequential cohort-wise manner across five cohorts

36 days

Multiple visits for dosing and PK sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• KSHN001034

Trial Overview The study involves giving participants either KSHN001034 or Faslodex through muscle or skin injections at various doses. They'll be monitored in groups (cohorts) with safety checks before moving to higher doses.

Participant Groups

Group I: Cohort 5 Experimental Treatment 2 Interventions

Group II: Cohort 4 Experimental Treatment 2 Interventions

Group III: Cohort 3 Experimental Treatment 2 Interventions

Group IV: Cohort 2 Experimental Treatment 2 Interventions

Group V: Cohort 1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Kashiv BioSciences, LLC

Lead Sponsor

Trials

4

Recruited

1,200+

Eric Solutions LLC

Collaborator

Trials

2

Recruited

50+

Clinexcel Research, Ahmedabad, India

Collaborator

Trials

1

Recruited

20+