KSHN001126 for Healthy Postmenopausal Women

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

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an Open-label, Sequential dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of KSHN001126 in Healthy Human Post-Menopausal Female Volunteers. 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 evaluate the plasma PK profile of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126.

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+