Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03611608 | A Study of LY3316531 in Healthy Participants | PHASE1 | COMPLETED | 16 | — | — | Aug 30, 2018 | Mar 15, 2019 | Aug 20, 2024 | 1 | Belgium |
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
| 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 |
| Name | Type | Description |
|---|---|---|
| LY3316531 | DRUG | Administered IV |
| Placebo | 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...