Healthy Postmenopausal WomenPhase 1NCT06467201
SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females
A Phase 1 study testing KSHN001126 150mg, KSHN001126 300mg and KSHN001126 600mg in people with Healthy Postmenopausal Women, run by Amneal Pharmaceuticals, LLC at 2 sites in 2 countries.
Trial summary
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. 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?
- KSHN001126 150mg, KSHN001126 300mg and KSHN001126 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jun 2024to 12 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 years and Follicle Stimulating Hormone (FSH) > 40 mIU/mL. Amenorrhea should not be due to lactation).
- In good general health with no clinically significant illness seen on physical examination or ongoing medical history, as determined by the Investigator.
- Documented 12-lead ECG with no clinically significant abnormalities (with QTc interval between 360 to 440 msec), as determined by the Investigator in screening or Day 0.
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- 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).
- Female participants must have a negative serum pregnancy (β-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female participants must also be non-lactating.
- The participant is available to volunteer for the entire study duration and is willing to adhere to all protocol requirements.
- The participant has vital signs at screening, and at check-in within the following ranges:
- Blood Pressure:
- Systolic: (100- 140 mmHg
- Diastolic: (60-90) mmHg
- Body Temperature: (36.1 - 37.8) ºC, Pulse rate: 60 to 100 b/m. Respiratory rate: 12 to 20 bpm
- Participants with normal findings as determined by gynecological examination and USG Pelvis.
- With a normal or clinically acceptable mammogram
- With a normal or clinically acceptable PAP smear test
- Have a normal chest X-ray (P. A. view).
- Participant negative for hepatitis B-surface antigen, hepatitis C and Human Immunodeficiency Virus (HIV)
- Participants who are generally healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
- Adequate venous access and can able to give required blood samples.
Who cannot join
- The participant is surgically induced postmenopausal female.
- Pregnant or lactating female participant.
- Any history of clinically significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the study results.
- History of allergy or major allergic reaction considered to be clinically significant by the Investigator.
- Receiving or has received any investigational drug within the 30 days before receiving KSHN001126.
- History or presence of low platelet count, bleeding issues or family history of bleeding disorders.
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- Participant has a history of hypersensitivity to heparin as checked at screening.
- The participant has known allergy to the drug under investigation, or to any ingredient in the preparation
- The participant has an evidence of antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements.
- Donated blood within 60 days of screening or otherwise experienced blood loss of >250 mL within the same period.
- Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug.
- Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
- Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment.
- History of drug and/or alcohol dependence within past 12 months, and/or positive results on drug of abuse or alcohol tests.
- The participant is a smoker (smoker is defined as reporting tobacco use in the previous 3 months and/or has urine cotinine level equal or more than 500 ng/ml)
- Has taken any regular, prescribed, or over-the-counter medication with the exception of acetaminophen (maximum 2 g/day) or multi- vitamins in the 2 weeks prior to dosing (other medication may only be taken with the specific approval of the Investigator in consultation with the Medical Monitor).
- The participant with history of consuming alcohol or caffeine or related xanthine containing foods or beverages such as caffeine in tea, coffee, chocolates, cola and pepsi for 48 hours prior to dosing.
- The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.
- Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma and carcinoma in situ uteri.
- The participant has prior history of hormonal replacement therapy.
- The participant has any estrogen- dependent conditions including breast cancer.
- Any condition that, in the opinion of the investigator, might interfere with study objectives.
- The participant has a history of osteoporosis or any disease affecting bone or steroid metabolism.
- Intolerance to/ fear of venipuncture, needles, or blood draws
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-label, Sequential Dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Human Post-Menopausal Female Volunteers
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.
- Conditions
- Healthy Postmenopausal Women
- Being tested
- KSHN001126 150mg, KSHN001126 300mg, KSHN001126 600mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSHN001126 150mgDrug
6 subjects will receive single oral dose of 150mg
KSHN001126 300mgDrug
6 subjects will receive single oral dose of 300mg
KSHN001126 600mgDrug
6 subjects will receive single oral dose of 600mg
| Study group | Role | What they receive |
|---|---|---|
| KSHN001126 150mg | Experimental | Low Dose Receives: Drug: KSHN001126 150mg |
| KSHN001126 300mg | Experimental | Mid Dose Receives: Drug: KSHN001126 300mg |
| KSHN001126 600mg | Experimental | High Dose Receives: Drug: KSHN001126 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs)
Adverse events reported after dosing will be evaluated
Measured: Upto Day 15 after dosing
Number of participants with abnormal laboratory tests results
Laboratory abnormalities after dosing will be evaluated
Measured: Upto Day 15 after dosing
Number of participants with abnormal vital signs
Measured: Upto Day 15 after dosing
Number of participants with abnormal Electrocardiogram readings
Impact on QTc interval will be evaluated
Measured: Upto Day 15 after dosing
Secondary outcomes (4)
Evaluate the Peak Plasma Concentration (Cmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Measured: 72 hours after dosing
Evaluate the Area under the plasma concentration versus time curve (AUC) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Measured: 72 hours after dosing
Evaluate the Time to maximum concentration (Tmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Measured: 72 hours after dosing
Evaluate the half life (T1/2) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Measured: 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start3 Jun 2024
- Primary completion8 Dec 2024
- Study completion12 Mar 2025
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467201
- Sponsor's protocol ID
- CE-24-02
- Status last verified
- Feb 2026
- First submitted
- 8 Jun 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Sequential Dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Human Post-Menopausal Female Volunteers
- ClinicalTrials.gov ID
- NCT06467201
- Acronym / sponsor ID
- CE-24-02
- Conditions
- Healthy Postmenopausal Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 20 Jun 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KSHN001126 150mg | Experimental | Drug: KSHN001126 150mgLow Dose |
| KSHN001126 300mg | Experimental | Drug: KSHN001126 300mgMid Dose |
| KSHN001126 600mg | Experimental | Drug: KSHN001126 600mgHigh Dose |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 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 40 years and Follicle Stimulating Hormone (FSH) > 40 mIU/mL. Amenorrhea should not be due to lactation).
- In good general health with no clinically significant illness seen on physical examination or ongoing medical history, as determined by the Investigator.
Key exclusion criteria (24 listed)
- The participant is surgically induced postmenopausal female.
- Pregnant or lactating female participant.
- Any history of clinically significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the study results.
- History of allergy or major allergic reaction considered to be clinically significant by the Investigator.
- Receiving or has received any investigational drug within the 30 days before receiving KSHN001126.
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 |
|---|---|---|
| KSHN001126 150mg6 subjects will receive single oral dose of 150mg | Drug | KSHN001126 150mg |
| KSHN001126 300mg6 subjects will receive single oral dose of 300mg | Drug | KSHN001126 300mg |
| KSHN001126 600mg6 subjects will receive single oral dose of 600mg | Drug | KSHN001126 600mg |
Primary outcome
Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs)
Time frame: Upto Day 15 after dosing
Adverse events reported after dosing will be evaluated
Number of participants with abnormal laboratory tests results
Time frame: Upto Day 15 after dosing
Laboratory abnormalities after dosing will be evaluated
Number of participants with abnormal vital signs
Time frame: Upto Day 15 after dosing
Number of participants with abnormal Electrocardiogram readings
Time frame: Upto Day 15 after dosing
Impact on QTc interval will be evaluated
4 secondary outcomes
Evaluate the Peak Plasma Concentration (Cmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Time frame: 72 hours after dosing
Evaluate the Area under the plasma concentration versus time curve (AUC) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Time frame: 72 hours after dosing
Evaluate the Time to maximum concentration (Tmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Time frame: 72 hours after dosing
Evaluate the half life (T1/2) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
Time frame: 72 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 KSHN001126 150mg, KSHN001126 300mg and KSHN001126 600mg in people with Healthy Postmenopausal Women, run by Amneal Pharmaceuticals, 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 21 inclusion and 24 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: finished, as of the sponsor's last update on 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs) (time frame: Upto Day 15 after dosing). The study lists 4 primary outcomes in all. 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 19 Feb 2026.