| CTRI Number |
CTRI/2025/11/097715 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A first-stage study to check how safe a new medicine (KSHN001034) is, how well people can tolerate it, and how the body absorbs and processes it, in healthy women who have reached menopause |
|
Scientific Title of Study
|
A Phase 1, Open Label, Randomized, Multiple Ascending Dose (MAD) Study Evaluating the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CE-24-06 Version 3.0 Dated 06 JAN 2025 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Pawan Singh |
| Designation |
Vice President and Head of Clinical Development |
| Affiliation |
Kashiv Biosciences LLC |
| Address |
FP 27/2, 43, TP-86, Block-B, Sardar Patel Ring Rd, opp. Applewoods Township, Ahmedabad, Gujarat 382210
Ahmadabad
GUJARAT
382210
India |
| Phone |
7666522355 |
| Fax |
|
| Email |
pawan.singh@kashivindia.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Pawan Singh |
| Designation |
Vice President and Head of Clinical Development |
| Affiliation |
Kashiv Biosciences LLC |
| Address |
FP 27/2, 43, TP-86, Block-B, Sardar Patel Ring Rd, opp. Applewoods Township, Ahmedabad, Gujarat 382210
Ahmadabad
GUJARAT
382210
India |
| Phone |
7666522355 |
| Fax |
|
| Email |
pawan.singh@kashivindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Medical Director |
| Affiliation |
Clinexcel Research |
| Address |
297/301, SoBo Center, South Bopal, ahmedabad.
Ahmadabad
GUJARAT
380058
India |
| Phone |
07600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
|
Source of Monetary or Material Support
|
| Kashiv Biosciences, LLC., 20 New England Ave, Piscataway, NJ 08854 |
|
|
Primary Sponsor
|
| Name |
Kashiv Biosciences, LLC. |
| Address |
20 New England Ave, Piscataway, NJ 08854 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Kashiv Biosciences Pvt Ltd |
FP 27/2, 43, TP-86, Block B. OPP. APPLEWOOD Township, SP Ring road, Ahmedabad, Gujarat India, 382210 |
|
|
Countries of Recruitment
|
India
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neel Lahoti |
Synergen Bio Pvt. Ltd. |
Sai chambers, 101-104, Old Mumbai - Pune Hwy, opp. Bajaj Showroom, Wakadewadi, Shivajinagar, Pune,
Pune
MAHARASHTRA |
020 2554 0555
neel@synergenbio.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Postmenopausal Female Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fulvestrant 500 mg |
500 mg fulvestrant administered intramuscularly (IM) on Days 1 and 15 |
| Intervention |
KSHN001034 |
100 mg fulvestrant equivalent of KSHN001034 administered intramuscularly (IM) on Days 1, 8, 15, and 22 (Q7D) |
| Intervention |
KSHN001034 |
100 mg fulvestrant equivalent of KSHN001034 administered subcutaneously (SC) on Days 1, 8, 15, and 22 (Q7D) |
| Intervention |
KSHN001034 |
200 mg fulvestrant equivalent of KSHN001034 administered intramuscularly (IM) on Days 1, 8, 15, and 22 (Q7D) |
| Intervention |
KSHN001034 |
200 mg fulvestrant equivalent of KSHN001034 administered subcutaneously (SC) on Days 1, 8, 15, and 22 (Q7D) |
| Intervention |
KSHN001034 |
300 mg fulvestrant equivalent of KSHN001034 administered intramuscularly (IM) on Days 1, 8, 15, and 22 (Q7D) |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures.
2. Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination.
3. Body Mass Index at screening between 18 and 30 kg/m2, inclusive.
4. 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 Ater the age of 45 years and FSH greater than 40 mIU/mL
1. Note: Amenorrhea should not be due to lactation).
5. 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).
6. Hemoglobin at screening and Day (-1) should be greater than or equal to 11 g/dL
7. Ability to communicate well and to comply with the requirements of the entire study.
8. Adequate venous access and can able to give required blood samples. |
|
| ExclusionCriteria |
| Details |
1. 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 participants ability to participate in the study.
2. Evidence of organ dysfunction [e.g. liver dysfunction; greater than or equal to Upper Limit of Normal (ULN) for ALT, AST or ALP or renal dysfunction (less than 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.
3. QTc (Bazzett) interval greater than or equal to 450 ms on ECG at screening.
4. Any major surgery requiring general anesthesia within 3 months prior to screening.
5. 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
6. History or presence of malignancy in the last 5 years
7. 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.
8. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation.
9. Donated blood within 60 days of screening or otherwise experienced blood loss of greater than 250 mL within the same period.
10. Presence of low platelet count (i.e. lower than LLN), bleeding issues or family history of bleeding disorders.
11. Participant has a history of hypersensitivity to heparin as checked at screening.
12. History of hypersensitivity or idiosyncratic reaction to test drug or any drug chemically similar to the drug under investigation or any of the excipients.
13. The participant has any estrogen- dependent conditions including benign breast conditions
14. The participant has a history of osteoporosis or any disease affecting bone or steroid etabolism.
15. Intolerance to/ fear of venipuncture, needles, or blood draws.
16. Positive serum pregnancy test during screening or Lactating mothers
17. 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.
18. 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
19. The participant has consumed grapefruit-containing beverages and foods 7 days prior to dosing.
20. Any condition that, in the opinion of the investigator, might interfere with study objectives.
21. Subjects with abnormal international normalized ratio (INR) at screening
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability of KSHN001034 as assessed by number of participants with Seriou Adverse Events (SAEs), Adverse Events (AEs) resulting in trial discontinuation, severity (by NCI CTCAE v5.0) and causality across test and reference arms |
Safety and tolerability of KSHN001034 as assessed by number of participants with Seriou Adverse Events (SAEs), Adverse Events (AEs) resulting in trial discontinuation, severity (by NCI CTCAE v5.0) and causality across test and reference arms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PK parameters including but not limited to Cmax, Cmin, Tmax, AUClast, AUC0-tau, Tlast, Clast, T1/2 and MRT. |
Up to Day 36 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Phase 1, open-label, randomized, multiple ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics of KSHN001034, an investigational drug intended as a fulvestrant equivalent, in healthy postmenopausal female volunteers. Approximately 40 participants will be enrolled across five cohorts, each receiving ascending intramuscular (IM) or subcutaneous (SC) doses of KSHN001034 (equivalent to 100 mg, 200 mg, or 300 mg fulvestrant) administered once weekly (Q7D) on Days 1, 8, 15, and 22. A comparator arm using 500 mg fulvestrant IM on Days 1 and 15 is included in each cohort. Safety assessments, including adverse event monitoring and laboratory evaluations, will be conducted from baseline through the end-of-study visit on Day 36. Pharmacokinetic sampling will occur throughout the dosing period and at follow-up to evaluate key PK parameters such as Cmax, Cmin, Tmax, AUC, and half-life. The study aims to determine the tolerability profile and PK characteristics of KSHN001034 to support further clinical development.
|