Is NCT06995482 recruiting in Miami Lakes, FL?

Yes, NCT06995482 is currently recruiting participants at its Miami Lakes, FL location. This healthy postmenopausal women clinical trial is actively enrolling qualified participants.

How do I join the healthy postmenopausal women clinical trial in Miami Lakes?

To join this clinical trial in Miami Lakes, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami Lakes clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Healthy Postmenopausal Women Clinical Trial in Miami Lakes, FL

About This Healthy Postmenopausal Women Study in Miami Lakes

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).

Sponsor: Kashiv BioSciences, LLC

Who Can Participate

Inclusion Criteria

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

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

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

Post-menopausal females (Menopause is defined as the female is either 12 months off menstrual period after the age of 50 years, or 12 months off menstrual period after the age of 45 years and FSH \> 40 mIU/mL Note: Amenorrhea should not be due to lactation).

Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead Electrocardiogram (ECG) performed during screening and as determined by the Principal Investigator (PI).

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

Ability to communicate well and to comply with the requirements of the entire study.

Adequate venous access and can able to give required blood samples.

Exclusion Criteria

History or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease or any other clinical significant abnormalities during screening investigations which, in the opinion of the PI, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.

Evidence of organ dysfunction \[e.g. liver dysfunction; ≥ Upper Limit of Normal (ULN) for ALT, AST or ALP or renal dysfunction (\<90 mL/min of creatinine clearance by Cockroft-Gault formula\] or any clinically significant abnormalities in other clinical laboratory parameters at screening as determined by the investigator.

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

Any major surgery requiring general anesthesia within 3 months prior to screening.

Known or suspected history of alcohol dependency or addictive substance use, as judged by the investigator Note: Participants will be required to abstain from recreational use of soft addictive substances (such as marijuana) within 2 weeks or hard addictive substances (such as cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives) within 2 months prior to screening

History or presence of malignancy in the last 5 years

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.

Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.

Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period.

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

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

History of hypersensitivity or idiosyncratic reaction to test drug or any drug chemically similar to the drug under investigation or any of the excipients.

The participant has any estrogen- dependent conditions including benign breast conditions

The participant has a history of osteoporosis or any disease affecting bone or steroid metabolism.

Intolerance to/ fear of venipuncture, needles, or blood draws.

Positive serum pregnancy test during screening or Lactating mothers

Has received another new chemical entity/investigational drug within 28 days or 5 half-lives of investigational drug (whichever is longer) of the first administration of investigational product in this study.

Use of any prescribed or non-prescribed medication, herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of investigational product.

The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.

Any condition that, in the opinion of the investigator, might interfere with study objectives.

Subjects with abnormal international normalized ratio (INR) at screening

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami Lakes?

Yes, this clinical trial (NCT06995482) has an active research site in Miami Lakes, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Healthy Postmenopausal Women Treatment Options in Miami Lakes, FL

If you're searching for healthy postmenopausal women treatment options in Miami Lakes, FL, this clinical trial (NCT06995482) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami Lakes research site is actively enrolling participants for this clinical trial. You'll receive care from experienced healthy postmenopausal women specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all healthy postmenopausal women clinical trials near you to find additional studies recruiting in your area.

Healthy Postmenopausal Women Clinical Trial in Miami Lakes, FL

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