Healthy Postmenopausal WomenPhase 1NCT06995482
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers
A Phase 1 study testing KSHN001034 and Fulvestrant in people with Healthy Postmenopausal Women, run by Kashiv BioSciences, LLC at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Postmenopausal Women
- What is being tested?
- KSHN001034 and Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Aug 2025to Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Floridian Clinical Research LLC
Miami Lakes, Florida, 33016
Sachin Bidani, 786-636-5556, sachinbidani@ericsolutions.com
India1 site, 1 recruiting
- Recruiting
Synergen Bio Pvt. Ltd.
Pune, Maharashtra, 411003
Jayesh Sanmukhani, +917600012192, drjayesh@clinexcelresearch.com
About this study
Official title: A Phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) Study Evaluating the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers
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:
Read more
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).
Read the detailed description
A phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of KSHN001034 in comparison with US-licensed Faslodex® (Fulvestrant) administered through intramuscular (IM) and subcutaneous (SC) routes in healthy postmenopausal female volunteers. Participants will be randomized in a 3:1 ratio to receive either KSHN001034 (administered IM or SC at low, medium, or high dose in five cohorts) or the reference product, Faslodex® (500 mg IM). Dose escalation will proceed cohort-wise, based on DSMB review of cumulative safety and PK data. PK blood samples will be collected from Day 1 to Day 36 across multiple pre- and post-dose timepoints to estimate PK parameters. Safety assessments include adverse events (AEs), serious adverse events (SAEs) as assessed by CTCAE v5.0.
- Conditions
- Healthy Postmenopausal Women
- Being tested
- KSHN001034, Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSHN001034Drug
Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.
- 6 subjects will receive low dose of KSHN001034 IM on Days 1, 8, 15, and 22.
KSHN001034Drug
Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.
- 6 subjects will receive medium dose of KSHN001034 IM on Days 1, 8, 15, and 22.
KSHN001034Drug
Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.
- 6 subjects will receive high dose of KSHN001034 IM on Days 1, 8, 15, and 22.
KSHN001034Drug
Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.
- 6 subjects will receive low dose of KSHN001034 SC on Days 1, 8, 15, and 22.
KSHN001034Drug
Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA.
- 6 subjects will receive medium dose of KSHN001034 SC on Days 1, 8, 15, and 22.
FulvestrantDrug
Reference Product: Faslodex® (Fulvestrant), 5 mL pre-filled syringe containing 250 mg/5 mL of fulvestrant, administered as two 5 mL injections (total 500 mg) via intramuscular (IM) injection. Marketed by AstraZeneca.
- 2 subjects will receive 500 mg Fulvestrant IM on Days 1 and 15.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: KSHN001034; Drug: Fulvestrant |
| Cohort 2 | Experimental | Not described Receives: Drug: KSHN001034; Drug: Fulvestrant |
| Cohort 3 | Experimental | Not described Receives: Drug: KSHN001034; Drug: Fulvestrant |
| Cohort 4 | Experimental | Not described Receives: Drug: KSHN001034; Drug: Fulvestrant |
| Cohort 5 | Experimental | Not described Receives: Drug: KSHN001034; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related Adverse events as assessed by CTCAE v5.0
Adverse events reported after dosing will be evaluated
Measured: up to 36 days after dosing
Secondary outcomes (4)
Pharmacokinetic parameter
Evaluate the Peak Plasma Concentration (Cmax)
Measured: upto day 36 after dosing
Pharmacokinetic parameter
Evaluate the Area under the plasma concentration versus time curve (AUC)
Measured: upto day 36 after dosing
Pharmacokinetic parameter
Evaluate the Time to maximum concentration (Tmax)
Measured: up to 36 days after dosing
Pharmacokinetic parameter
Evaluate the half life (T1/2)
Measured: up to 36 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start18 Aug 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kashiv BioSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eric Solutions LLC, Clinexcel Research, Ahmedabad, India
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995482
- Sponsor's protocol ID
- CE-24-06
- Status last verified
- Feb 2026
- First submitted
- 19 May 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) Study Evaluating the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers
- ClinicalTrials.gov ID
- NCT06995482
- Acronym / sponsor ID
- CE-24-06
- Conditions
- Healthy Postmenopausal Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kashiv BioSciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Eric Solutions LLC, Clinexcel Research, Ahmedabad, India
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of KSHN001034 in comparison with US-licensed Faslodex® (Fulvestrant) administered through intramuscular (IM) and subcutaneous (SC) routes in healthy postmenopausal female volunteers. Participants will be randomized in a 3:1 ratio to receive either KSHN001034 (administered IM or SC at low, medium, or high dose in five cohorts) or the reference product, Faslodex® (500 mg IM). Dose escalation will proceed cohort-wise, based on DSMB review of cumulative safety and PK data. PK blood samples will be collected from Day 1 to Day 36 across multiple pre- and post-dose timepoints to estimate PK parameters. Safety assessments include adverse events (AEs), serious adverse events (SAEs) as assessed by CTCAE v5.0.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: KSHN001034, Drug: Fulvestrant |
| Cohort 2 | Experimental | Drug: KSHN001034, Drug: Fulvestrant |
| Cohort 3 | Experimental | Drug: KSHN001034, Drug: Fulvestrant |
| Cohort 4 | Experimental | Drug: KSHN001034, Drug: Fulvestrant |
| Cohort 5 | Experimental | Drug: KSHN001034, Drug: Fulvestrant |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSHN001034Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive low dose of KSHN001034 IM on Days 1, 8, 15, and 22. | Drug | Cohort 1 |
| KSHN001034Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive medium dose of KSHN001034 IM on Days 1, 8, 15, and 22. | Drug | Cohort 2 |
| KSHN001034Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive high dose of KSHN001034 IM on Days 1, 8, 15, and 22. | Drug | Cohort 3 |
| KSHN001034Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive low dose of KSHN001034 SC on Days 1, 8, 15, and 22. | Drug | Cohort 4 |
| KSHN001034Test Product: KSHN001034, 5 mL vial containing 113 mg/mL of KSHN001034, equivalent to 100 mg/mL of fulvestrant. Manufactured for Kashiv Biosciences LLC, USA. • 6 subjects will receive medium dose of KSHN001034 SC on Days 1, 8, 15, and 22. | Drug | Cohort 5 |
| FulvestrantReference Product: Faslodex® (Fulvestrant), 5 mL pre-filled syringe containing 250 mg/5 mL of fulvestrant, administered as two 5 mL injections (total 500 mg) via intramuscular (IM) injection. Marketed by AstraZeneca. • 2 subjects will receive 500 mg Fulvestrant IM on Days 1 and 15. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Number of participants with treatment-related Adverse events as assessed by CTCAE v5.0
Time frame: up to 36 days after dosing
Adverse events reported after dosing will be evaluated
4 secondary outcomes
Pharmacokinetic parameter
Time frame: upto day 36 after dosing
Pharmacokinetic parameter
Time frame: upto day 36 after dosing
Pharmacokinetic parameter
Time frame: up to 36 days after dosing
Pharmacokinetic parameter
Time frame: up to 36 days after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KSHN001034 and Fulvestrant in people with Healthy Postmenopausal Women, run by Kashiv BioSciences, LLC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pawan Singh (+91 7666522355, pawan.singh@kashivindia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related Adverse events as assessed by CTCAE v5.0 (time frame: up to 36 days after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.