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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03913260 | A Study of Different Injectable Formulations of LY3375880 in Healthy Participants | PHASE1 | COMPLETED | 83 | — | — | May 1, 2019 | Sep 19, 2019 | Oct 11, 2019 | 2 | United States |
| NCT03343587 | A Study of LY3375880 in Healthy Participants | PHASE1 | COMPLETED | 80 | — | — | Nov 17, 2017 | Nov 16, 2018 | Dec 10, 2018 | 1 | United States |
The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
PK: Cmax of LY3375880
PK: AUC of LY3375880
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Part A: LY3375880 Formulation A | EXPERIMENTAL | LY3375880 Formulation A administered subcutaneously (SC). |
| Part A: LY3375880 Formulation B | EXPERIMENTAL | LY3375880 Formulation B administered subcutaneously SC. |
| Part A: LY3375880 Formulation C | EXPERIMENTAL | LY3375880 Formulation C administered SC. |
| Part A: Positive Control | PLACEBO_COMPARATOR | Positive Control (buffer matrix, only) administered SC. |
| Part B: LY3375880 Test 1 | EXPERIMENTAL | LY3375880 Test 1 Formulation administered SC. |
| Part B: LY3375880 Test 2 | EXPERIMENTAL | LY3375880 Test 2 Formulation administered SC. |
| Part B: LY3375880 Test 3 | EXPERIMENTAL | LY3375880 Test 3 Formulation administered SC. |
| LY3375880 Single Dose | EXPERIMENTAL | Single dose of LY3375880 administered IV or SC |
| Placebo Single Dose | PLACEBO_COMPARATOR | Single dose of placebo administered IV or SC |
| LY3375880 Multiple Dose | EXPERIMENTAL | Multiple doses of LY3375880 administered IV or SC |
| Placebo Multiple Dose | PLACEBO_COMPARATOR | Multiple doses of placebo administered IV or SC |
| Name | Type | Description |
|---|---|---|
| LY3375880 | DRUG | Administered SC |
| Buffer Matrix (No LY3375880) | DRUG | Administered SC |
| Autoinjector (AI) | DEVICE | AI used to administer LY3375880 or Buffer Matrix |
| Manual Syringe | DEVICE | Manual syringe used to inject LY3375880 |
| LY3375880 IV | DRUG | administered IV |
| LY3375880 SC | DRUG | administered SC |
| Placebo IV | DRUG | administered IV |
| Placebo SC | DRUG | administered SC |
Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive * Females who are not of child-bearing potential * Males who agree to use a reliable method of...