Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3323795 · 1 trial · 1 indication
Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| LY3323795 (Part A) | EXPERIMENTAL | Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Participants received placebo identical to LY3323795 orally. |
| LY3323795 (Part B) | EXPERIMENTAL | Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Participants received placebo identical to LY3323795 orally. |
| LY3323795 (Part C) | EXPERIMENTAL | Part C was not initiated due to a Lilly internal strategy decision. |
| LY3323795 + Itraconazole (Part C) | EXPERIMENTAL | Part C was not initiated due to a Lilly internal strategy decision. |
| Name | Type | Description |
|---|---|---|
| LY3323795 | DRUG | Administered orally |
| Itraconazole | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Healthy males or females of non-childbearing potential at time of screening * Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0 kg/m², inclusive Exclusion Criteria: * Have participated, within the last 30 days, in a clinical trial involvin...
LY3323795 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development, studied in healthy participants. The drug is not approved and remains under investigation.
LY3323795 is being studied in healthy participants as part of early clinical development. Its intended therapeutic use has not been established, and it is not approved for any condition.
LY3323795 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.
LY3323795 is in Phase 1 clinical development. A Phase 1 study in healthy participants has been completed, and the drug remains investigational.
LY3323795 has one completed Phase 1 trial, NCT02989389, titled "A Study of LY3323795 in Healthy Participants." This randomized, double-blind, placebo-controlled study enrolled 42 healthy participants in the United States.
LY3323795 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy participants and remains in clinical development.