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Tests treatment safety and results for Healthy Postmenopausal Women
Official title Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers
ClinicalTrials.gov ID: NCT06995482
What this study is testing
What is KSHN001034?
KSHN001034 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy postmenopausal women.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead Electrocardiogram (ECG) performed...
You likely can't join if
- History or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic...
- 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...
- 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...
- History or presence of malignancy in the last 5 years
See the full eligibility 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...
- 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.
- History or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease or any other clinical significant...
- 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...
- 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...
- 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...
- 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.
- people with abnormal international normalized ratio (INR) at screening
The study team makes the final eligibility decision.
Where it's taking place
- Miami Lakes, Florida, United States
- Pune, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Lakes, Florida, United States; Pune, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.