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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03886948 | A Study of Injections of LY3074828 in Healthy Participants | PHASE1 | COMPLETED | 66 | — | — | Mar 27, 2019 | Oct 4, 2019 | Feb 20, 2024 | 1 | United States |
| NCT03748940 | Study of LY3074828 in Healthy Participants | PHASE1 | COMPLETED | 60 | — | — | Oct 10, 2018 | Jun 18, 2019 | Jul 19, 2019 | 1 | United Kingdom |
| NCT03662100 | A Study of Two Formulations of LY3074828 in Healthy Participants | PHASE1 | COMPLETED | 66 | — | — | Sep 6, 2018 | Jan 25, 2019 | Jan 25, 2024 | 1 | United States |
| NCT03456713 | A Study of LY3074828 in Healthy Participants | PHASE1 | COMPLETED | 72 | — | — | Mar 6, 2018 | Aug 13, 2018 | Feb 20, 2024 | 1 | United States |
| NCT03220126 | A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants | PHASE1 | COMPLETED | 72 | — | — | Jul 17, 2017 | Feb 23, 2018 | Mar 29, 2018 | 1 | United Kingdom |
| NCT03188510 | A Study of Two Different Formulations of LY3074828 in Healthy Participants | PHASE1 | COMPLETED | 54 | — | — | Jun 30, 2017 | Nov 27, 2017 | Jan 25, 2024 | 1 | United States |
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3074828
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 horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain).
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 horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain).
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).
Pharmacokinetics: Cmax of LY3074828
Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-inf\]) of LY3074828
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to tlast (AUC\[0-tlast\]) of LY3074828
Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). Least Squares (LS) mean was calculated using linear fixed-effects model with treatment (Reference or Test 1) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.
Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). LS mean was calculated using linear fixed-effects model with treatment (Test 2 or Test 3) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.
Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). LS mean was calculated using linear fixed-effects model with treatment (Test 4 or Test 5) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.
PK: AUC of LY3074828
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC\[0-tlast\]) of LY3074828 was evaluated. Unit of measure expansion: microgram\*day per milliliter per milligram (µg\*day/mL/mg).
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC\[0-∞\]) of LY3074828 was evaluated.
| Arm | Type | Description |
|---|---|---|
| 125 mg LY3074828 Prefilled Syringe (PFS) | EXPERIMENTAL | Reference 1: Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL pre-filled syringe (PFS) administered in the arm. Reference 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh. Reference 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen. |
| 125 mg LY3074828 Autoinjector (AI) | EXPERIMENTAL | Test 1: Participants received 125 mg LY3074828 solution formulation SC via 1-mL Autoinjector (AI) administered in the arm. Test 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh. Test 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen. |
| Part A: Placebo | PLACEBO_COMPARATOR | Placebo administered subcutaneously (SC) |
| Part A: LY3074828 | EXPERIMENTAL | LY3074828 administered SC |
| Part B: Placebo | PLACEBO_COMPARATOR | Placebo administered SC |
| Part B: LY3074828 | EXPERIMENTAL | LY3074828 administered SC |
| Part B: LY900021 | EXPERIMENTAL | LY900021 (LY3074828 + LY9999QS) administered SC |
| Test 1: 250 mg LY3074828 | EXPERIMENTAL | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter \[mg/mL\]) administered subcutaneously (SC) via an auto-injector (AI) in arm. |
| Test 2: 250 mg LY3074828 | EXPERIMENTAL | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh. |
| Test 3: 250 mg LY3074828 | EXPERIMENTAL | Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen. |
| Reference 1: 250 mg LY3074828 | EXPERIMENTAL | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm. The second injection was administered 20 (±2) minutes after the first injection. |
| Reference 2: 250 mg LY3074828 | EXPERIMENTAL | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh. The second injection was administered 20 (±2) minutes after the first injection. |
| Reference 3: 250 mg LY3074828 | EXPERIMENTAL | Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen. The second injection was administered 20 (±2) minutes after the first injection. |
| Part A: 250 mg LY3074828 (Reference) | EXPERIMENTAL | 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1. |
| Part A: 250 mg LY3074828 (Test 1) | EXPERIMENTAL | 250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1. |
| Part B: 250 mg LY3074828 (Test 2 and Test 3) | EXPERIMENTAL | Test 2: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at slow speed targeting an approximately 13-second injection time on day 1. Test 3: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at fast speed targeting an approximately 5-second injection time on day 2. |
| Part B: 125 mg LY3074828 (Test 4 and Test 5) | EXPERIMENTAL | Test 4: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at slow speed targeting an approximately 7-second injection time on day 1. Test 5: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at fast speed targeting an approximately 4.5-second injection time on day 2. |
| LY3074828 - Treatment 1 | EXPERIMENTAL | Single intravenous (IV) dose of LY3074828 |
| LY900021 - Treatment 2 | EXPERIMENTAL | Single subcutaneous (SC) dose of LY900021 (LY3074828 coadministered with LY9999QS) |
| LY900021 - Treatment 3 | EXPERIMENTAL | Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS) |
| LY900021 - Treatment 4 | EXPERIMENTAL | Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS) |
| Reference: 250 mg LY3074828 | EXPERIMENTAL | 250 mg LY3074828 lyophilized formulation administered subcutaneously (SC) as 3 injections |
| Test 2: 500 mg LY3074828 | EXPERIMENTAL | 500 mg LY3074828 solution formulation administered as SC injections in four prefilled syringes |
| Name | Type | Description |
|---|---|---|
| LY3074828 | DRUG | Administered subcutaneously (SC) |
| Pre-filled syringe (PFS) | DEVICE | PFS used to administer LY3074828 |
| Autoinjector (AI) | DEVICE | AI used to administer LY3074828 |
| Placebo | DRUG | Administered SC |
| LY900021 | DRUG | Administered SC |
| Auto-injector (AI) | DEVICE | AI to administer LY3074828 |
| Prefilled syringe (PFS) | DEVICE | PFS to administer LY3074828 |
Inclusion Criteria: \- Must be healthy males or females Exclusion Criteria: * Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females) * Must not show evidence of active or latent tuberculosis (TB) * Must not have received live vaccine(s) (incl...