Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3316531 · 2 trials · 2 indications
To assess target neutralization of calcitonin gene-related peptide by LY3316531 versus placebo, the capsaicin-induced dermal blood flow was measured at baseline (before administration of LY3316531 or placebo) as well as 24 days after a single intravenous dose of LY3316531 or placebo
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
| Arm | Type | Description |
|---|---|---|
| 300 mg LY3316531 Dose 1 | EXPERIMENTAL | LY3316531 administered IV |
| LY3316531 Dose 2 | EXPERIMENTAL | The optional additional cohort (Dose 2) was not implemented as the data desired for treatment effect on dermal blood flow (DBF) was generated at the initial Dose 1 (300mg LY3316531) LY3316531 administered IV |
| Placebo | PLACEBO_COMPARATOR | Placebo administered IV |
| LY3316531 (Part A) | EXPERIMENTAL | Participants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC). |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo matching LY3316531 administered IV. |
| LY3316531 (Part B) | EXPERIMENTAL | Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks). |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo matching LY3316531 administered IV. |
| LY3316531 (Part C) | EXPERIMENTAL | Participants with psoriasis received single doses of 300 mg LY3316531 administered IV. |
| Name | Type | Description |
|---|---|---|
| LY3316531 | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
| LY3316531 - IV | DRUG | Administered IV. |
| LY3316531 - SC | DRUG | Administered SC. |
| Placebo - IV | DRUG | Administered IV. |
Inclusion Criteria: * Must be healthy males * Must be abstinent or use condoms with spermicide as well as 1 additional highly effective method of contraception or effective method of contraception during the study and for 5 months following dosing of study drug * Must have a body mass index between...
LY3316531 is an investigational small molecule being studied for the treatment of psoriasis. It has also been evaluated in healthy participants to assess its safety and tolerability. The drug is being developed by Eli Lilly and Company and is currently in Phase 1 clinical development.
LY3316531 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule in Phase 1 clinical development for psoriasis.
LY3316531 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed in healthy participants and in participants with psoriasis to evaluate the drug's safety and tolerability.
LY3316531 has been studied in two completed Phase 1 clinical trials. NCT03418493 evaluated the drug in healthy participants and participants with psoriasis in the United States, enrolling 63 participants. NCT03611608 evaluated the drug in healthy male participants in Belgium, enrolling 16 participants.
LY3316531 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have focused on safety and tolerability in healthy participants and in those with psoriasis, but the drug has not yet received regulatory approval.