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SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females
NCT06467201 · View on ClinicalTrials.gov ↗
Study 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. 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 Studied
Interventions
- DRUG KSHN001126 150mg
- DRUG KSHN001126 300mg
- DRUG KSHN001126 600mg
Study Locations (2)
Florida
- Advanced Pharma CR — Miami
Gujarat
- Health1 Superspeciality Hospital — Ahmedabad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2025-03-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06467201
The ClinicalTrials.gov registry entry for NCT06467201 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amneal Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Postmenopausal Women appearing as the primary indexed condition, and to 3 interventions — of which KSHN001126 150mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06467201 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Gujarat. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06467201 about?
NCT06467201 is a clinical study titled "SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females". 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 incre...
What is the current status of trial NCT06467201?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-06-03. Estimated completion is 2025-03-12.
What conditions does trial NCT06467201 study?
This clinical trial studies the following conditions: Healthy Postmenopausal Women. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06467201?
The interventions under investigation include: KSHN001126 150mg (DRUG), KSHN001126 300mg (DRUG), KSHN001126 600mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06467201?
This trial is sponsored by Amneal Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06467201 being conducted?
This trial has 2 study locations across Florida, Gujarat. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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