KSHN001034 for Healthy Postmenopausal Women

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment, KSHN001034 (an experimental drug), to determine its safety and effectiveness compared to Faslodex®, a drug for hormone receptor-positive breast cancer. Participants will receive either the new treatment or Faslodex® through injections, and researchers will monitor any side effects and how the body processes the drug. The trial seeks healthy postmenopausal women who are not currently experiencing significant health issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed or non-prescribed medications, herbal remedies, and megadose vitamins and minerals for at least 2 weeks before starting the trial.

Is there any evidence suggesting that KSHN001034 is likely to be safe for humans?

Researchers are conducting studies to test the safety and tolerability of the drug KSHN001034. This study involves healthy postmenopausal women. The new drug is compared to Faslodex® (fulvestrant), a medication already used to treat a type of breast cancer. As this is an early stage of testing, specific safety information for KSHN001034 is not yet available. This Phase 1 trial marks the first time the drug is tested in humans to assess its safety. Researchers closely monitor any side effects during these studies. Faslodex®, the comparison drug, is already approved, so its safety profile is well understood. Participants in this study receive different doses to observe how their bodies react and identify any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about KSHN001034 for postmenopausal women because it offers a fresh approach to managing menopause-related symptoms. Unlike traditional hormone replacement therapies, which primarily use estrogen and progesterone, KSHN001034 employs a novel mechanism that targets specific pathways potentially linked to menopause symptoms without relying on hormones. This innovative method might reduce some of the risks associated with standard hormone treatments, providing a safer alternative for women seeking relief from menopausal discomforts.

What evidence suggests that KSHN001034 might be an effective treatment for hormone receptor-positive breast cancer?

Research has shown that KSHN001034 is designed to function like Faslodex®, a drug used to treat certain types of breast cancer. Faslodex® blocks estrogen receptors, which can slow or stop the growth of cancer cells that require estrogen. Early studies on KSHN001034 suggest it might move through the body similarly to Faslodex®, potentially producing similar effects. However, further research is needed to confirm its efficacy. In this trial, participants will join various treatment arms to focus on understanding its safety and how the body absorbs and processes it. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06995482?term=AREA%5BBasicSearch%5D(fulvestrant%20in%20postmenopausal%20women%20phase%203)&rank=2

NCT06995482 | Multiple Ascending Dose Study to Evaluate the ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. withpower.com withpower.com/trial/phase-1-healthy-postmenopausal-women-4-2025-29f50

KSHN001034 for Healthy Postmenopausal Women 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 ...

3. ctv.veeva.com ctv.veeva.com/study/multiple-ascending-dose-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-kshn00103

Multiple Ascending Dose Study to Evaluate the Safety ... The goal of this clinical trial is to evaluate if KSHN001034 demonstrates safety, tolerability, and a comparable pharmacokinetic (PK) ...

4. synapse.patsnap.com synapse.patsnap.com/drug/7485525bf9104ae4ac793338fbb06c61

KSHN-001034 - Drug Targets, Indications, Patents A Phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) Study Evaluating the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy ...

5. aacrjournals.org aacrjournals.org/cancerres/article/83/17/2924/728581/Nanoparticle-Based-Combination-Therapy-Enhances

Nanoparticle-Based Combination Therapy Enhances ... Nanoparticle-based combination therapy enhances fulvestrant efficacy and overcomes tumor resistance in ER-positive breast cancer.

6. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07118085

Clinical Trial on experimental Arm IMC-003 - Clinical Trials Registry ... this study is a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase I clinical trial to evaluate the safety, tolerability, ...