Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KSHN001126 · 1 trial · 1 indication
Adverse events reported after dosing will be evaluated
Laboratory abnormalities after dosing will be evaluated
Impact on QTc interval will be evaluated
| Arm | Type | Description |
|---|---|---|
| KSHN001126 150mg | EXPERIMENTAL | Low Dose |
| KSHN001126 300mg | EXPERIMENTAL | Mid Dose |
| KSHN001126 600mg | EXPERIMENTAL | High Dose |
| Name | Type | Description |
|---|---|---|
| KSHN001126 150mg | DRUG | 6 subjects will receive single oral dose of 150mg |
| KSHN001126 300mg | DRUG | 6 subjects will receive single oral dose of 300mg |
| KSHN001126 600mg | DRUG | 6 subjects will receive single oral dose of 600mg |
Inclusion Criteria: 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 scr...
KSHN001126 is an investigational small molecule developed by Amneal Pharmaceuticals, Inc. (ticker AMRX). It has been studied in a Phase 1 clinical trial in healthy post-menopausal women. The specific therapeutic indication for KSHN001126 has not been disclosed, and the program remains in early clinical development.
KSHN001126 is being developed by Amneal Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker AMRX. Amneal is the sponsor of the Phase 1 study of the compound. The drug is also referred to as KSHN001126 150mg in some contexts.
KSHN001126 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA. The completed study enrolled 18 healthy post-menopausal female volunteers.
KSHN001126 has been evaluated in a single Phase 1 trial, NCT06467201, titled a single ascending dose study to evaluate safety, tolerability, and pharmacokinetic profile of AMN1126 in healthy post-menopausal females. The trial was completed and enrolled 18 participants across the United States and India.
The therapeutic indication for KSHN001126 has not been disclosed. The compound has been studied only in healthy post-menopausal female volunteers in a Phase 1 trial, not in a patient population with a specific disease. It is an investigational small molecule and is not approved for any use.