KSHN001126 for Healthy Postmenopausal Women

Not yet recruiting at 1 trial location

Overseen By Ganesh Sangle

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Shivanka Research, LLC

Must not be taking: Investigational drugs, Hormonal therapy

Disqualifiers: Cardiac, Renal, Hepatic, Neurologic, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new medication, KSHN001126, in healthy postmenopausal women. Researchers seek to understand how the body processes different doses of this medication and its breakdown products. It suits women who have not had a menstrual period for at least a year since turning 50 and are in generally good health without significant medical issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any regular prescribed or over-the-counter medications, except for acetaminophen (up to 2 g/day) or multivitamins, for 2 weeks before the trial. Other medications may only be taken with specific approval from the Investigator.

Is there any evidence suggesting that KSHN001126 is likely to be safe for humans?

Research is investigating the safety and tolerability of KSHN001126. Currently, no specific information from past studies exists about this treatment. This trial is in an early phase, marking one of the first tests in humans. Early-phase trials focus on ensuring safety and understanding how the body processes the treatment.

Researchers are testing different doses of KSHN001126 to observe the body's reactions. As an early-stage trial, the primary goal is to ensure the treatment does not cause harmful side effects. Detailed safety data from other studies is not yet available, but this phase prioritizes safety assessment. Participants will be closely monitored to quickly identify any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about KSHN001126 because it introduces a novel approach to managing health in postmenopausal women. Unlike standard hormone replacement therapies, which often rely on estrogen and progesterone to address menopause symptoms, KSHN001126 is being tested at various dosages to potentially offer a more tailored solution. This treatment is noteworthy for its flexibility in dosing, with options ranging from low to high doses (150mg, 300mg, and 600mg), allowing for personalized adjustments based on individual needs. This adaptability might lead to better outcomes with fewer side effects, a key reason for the enthusiasm surrounding this treatment.

What evidence suggests that KSHN001126 could be effective for postmenopausal women?

Research has shown that KSHN001126 is a form of the drug fulvestrant, which has demonstrated greater effectiveness in studies. Fulvestrant treats a type of breast cancer by breaking down estrogen receptors, suggesting that KSHN001126 might also address conditions related to estrogen. Early laboratory research indicates the drug works well. Although further studies with people are necessary, its mechanism suggests potential benefits for postmenopausal women. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy post-menopausal women who are willing to participate in a study evaluating the safety of a new drug. Specific eligibility criteria details were not provided.

Inclusion Criteria

The participant has vital signs at screening, and at check-in within specified ranges

With a normal or clinically acceptable PAP smear test

No clinically significant abnormalities in screening or Day 0 laboratory tests, as determined by the Investigator (Creatinine clearance should be ≥ 90 mL/min and Blood Urea Nitrogen / AST / ALT / Alkaline phosphatase / Total and direct bilirubin should be < upper limit of normal)

Exclusion Criteria

I am unable to undergo blood draws due to fear or intolerance.

Receiving or has received any investigational drug within the 30 days before receiving KSHN001126

Participant has a history of hypersensitivity to heparin as checked at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of KSHN001126 to evaluate safety, tolerability, and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and laboratory tests

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• KSHN001126

Trial Overview The trial tests three different doses (150mg, 300mg, and 600mg) of KSHN001126 to see how safe they are and how the body processes them. It's an open-label study where everyone knows what treatment they're getting.

How Is the Trial Designed?

Group I: KSHN001126 600mg Experimental Treatment 1 Intervention

High Dose

Group II: KSHN001126 300mg Experimental Treatment 1 Intervention

Mid Dose

Group III: KSHN001126 150mg Experimental Treatment 1 Intervention

Low Dose

Who Is Running the Clinical Trial?

Shivanka Research, LLC

Lead Sponsor

Trials

1

Recruited

20+

Eric Solutions LLC

Collaborator

Trials

2

Recruited

50+

Clinexcel Research, Ahmedabad, India

Collaborator

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06467201

NCT06467201 | SAD Study to Evaluate Safety, Tolerability, and ... Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination. Body Mass Index at screening ...

2. meddatax.com meddatax.com/clinical-trials/NCT06467201

SAD Study to Evaluate Safety, Tolerability, and ... SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of KSHN001126 in Healthy Post-Menopausal Females ... Healthy ...

3. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.e13027

Development of orally bioavailable prodrugs of fulvestrant ... Herewith, we report the identification of KSHN001022, KSHN001075, and KSHN001126, the prodrugs of fulvestrant, which showed enhanced efficacy ...

4. researchgate.net researchgate.net/publication/370180706_Phase_1_study_of_oral_selective_estrogen_receptor_degrader_SERD_amcenestrant_SAR439859_in_Japanese_women_with_ER-positive_and_HER2-negative_advanced_breast_cancer_AMEERA-2

Phase 1 study of oral selective estrogen receptor degrader ... Background This AMEERA-2 study evaluated the pharmacokinetics, efficacy, and safety of the oral selective estrogen receptor degrader ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11755967/

Fezolinetant's efficacy and safety in treatment of vasomotor ... Fezolinetant is a safe and effective treatment for postmenopausal females with VMS. Additionally, both doses of 30 mg and 45 mg reduced the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06467201

NCT06467201 | SAD Study to Evaluate Safety, Tolerability ... The primary objective of the study is to evaluate the safety and tolerability of increasing single doses of KSHN001126 while the secondary objective is to ...

7. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=28454153

Floridian Clinical Research LLC Trials NCT06467201: SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of KSHN001126 in Healthy Post-Menopausal Females. Not yet recruiting. 1.

8. 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 ... Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination. Body Mass Index ...