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NCT06995482 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers
A Phase 1 study of Healthy Postmenopausal Women, sponsored by Kashiv BioSciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT06995482: Recruiting Phase 1 study of Healthy Postmenopausal Women, sponsored by Kashiv BioSciences.
NCT06995482 is a Phase 1 study of Healthy Postmenopausal Women that is actively recruiting participants, run by Kashiv BioSciences. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06995482, a Phase 1 study of Healthy Postmenopausal Women, is actively recruiting participants, sponsored by Kashiv BioSciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study 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. 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).
Primary Outcome
Adverse events reported after dosing will be evaluated
Conditions Studied
Interventions
- DRUG KSHN001034
Study Locations (2)
Florida
- Floridian Clinical Research LLC - Miami Lakes
Maharashtra
- Synergen Bio Pvt. Ltd. - Pune
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-08-18 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT06995482 shows while recruiting
NCT06995482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Healthy Postmenopausal Women appearing as the primary indexed condition, and to 1 intervention - of which KSHN001034 is the first listed.
NCT06995482 reports a single indexed study location in Florida, Maharashtra.
Frequently Asked Questions
What is clinical trial NCT06995482 about?
NCT06995482 is a clinical study titled "Multiple Ascending Dose Study to Evaluate 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: Receive ei...
What is the current status of trial NCT06995482?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-08-18. Estimated completion is 2026-06.
What conditions does trial NCT06995482 study?
This clinical trial studies the following conditions: Healthy Postmenopausal Women.
What interventions are being tested in trial NCT06995482?
The interventions under investigation include: KSHN001034 (DRUG).
Who is sponsoring clinical trial NCT06995482?
This trial is sponsored by Kashiv BioSciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06995482 being conducted?
This trial has 2 study locations across Florida, Maharashtra. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06995482's enrollment target sits among peer trials
40 1131st of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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