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 being developed by Amneal Pharmaceuticals, Inc. (AMRX). It is currently in Phase 1 clinical development. The drug is being studied in healthy postmenopausal women, and it is not yet approved by the FDA.
KSHN001126 is being studied for use in healthy postmenopausal women. The ongoing clinical development focuses on evaluating its safety, tolerability, and pharmacokinetic profile in this population. It is an investigational drug and has not been approved for any medical condition.
KSHN001126 is being developed by Amneal Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol AMRX. The drug is currently in Phase 1 clinical trials, and Amneal is the sponsor of the ongoing research.
KSHN001126 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still undergoing clinical trials to assess its safety and tolerability in healthy postmenopausal women.
KSHN001126 has one completed clinical trial, identified by the NCT number NCT06467201. This was a single ascending dose (SAD) study that evaluated the safety, tolerability, and pharmacokinetic profile of AMN1126 in healthy post-menopausal females. The trial enrolled 18 participants and took place in the United States and India.
Yes, KSHN001126 is also known as AMN1126. In the clinical trial NCT06467201, the drug is referred to as AMN1126. Both names refer to the same investigational small molecule being developed by Amneal Pharmaceuticals.