Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KD025 · 1 trial · 1 indication
Area under the concentration-time curve from time 0 to infinity
Area under the concentration-time curve from time 0 to the last measurable concentration
Maximum observed concentration
Time of the observed maximum concentration
Terminal elimination half-life
Time of the last measurable concentration
Apparent total clearance
Apparent volume of distribution
| Arm | Type | Description |
|---|---|---|
| Normal Hepatic Function (Group 1--Control) | EXPERIMENTAL | Matched healthy subjects with normal hepatic function |
| Mild Hepatic Impairment (Group 2) | EXPERIMENTAL | Subjects with mild hepatic impairment based on Child-Pugh Class A score of 5 or 6 |
| Moderate Hepatic Impairment (Group 3) | EXPERIMENTAL | Subjects with moderate hepatic impairment based on Child-Pugh Class B score of 7 to 9 |
| Severe Hepatic Impairment (Group 4) | EXPERIMENTAL | Subjects with severe hepatic impairment based on Child-Pugh Class C score of 10 to 14 |
| Name | Type | Description |
|---|---|---|
| KD025 | DRUG | Single dose of 200 mg KD025 orally |
Inclusion Criteria: For All Subjects: Subjects must satisfy all of the following criteria at the Screening visit, unless otherwise stated: 1. Males or females, of any race, between 18 and 75 years of age, inclusive. 2. Body mass index between 18.0 and 38.0 kg/m\^2, inclusive. 3. Females of non-ch...
KD025 is an investigational small molecule being studied for hepatic impairment, a condition in which the liver is unable to function normally. It is being evaluated in a clinical trial that includes subjects with varying degrees of hepatic impairment as well as those with normal hepatic function.
KD025 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical research on this investigational drug for hepatic impairment.
KD025 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and effects in humans.
KD025 has one completed clinical trial registered under NCT04166942, titled "KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment." This Phase 1 study enrolled 35 participants in the United States and included healthy volunteers.
KD025 is not known to have alternative names. It is a distinct investigational small molecule being developed by Sanofi for hepatic impairment. No other names for this drug have been reported.