Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3074828 · 6 trials · 1 indication
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...
LY3074828 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 has been evaluated in six completed trials with a total enrollment of 390 participants.
LY3074828 is being studied in healthy participants as part of early clinical development. The trials assess how the drug enters the body, different formulations, and injections. It is not yet approved for any condition and remains in Phase 1 testing.
LY3074828 is developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting Phase 1 trials of this investigational small molecule in healthy volunteers.
LY3074828 is in Phase 1 clinical development. All six trials of the drug have been completed, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
LY3074828 has been studied in six completed Phase 1 trials, including NCT03220126, NCT03662100, NCT03748940, and NCT03886948. These trials enrolled healthy participants in the United Kingdom and United States, assessing drug levels, formulations, and injections.
LY3074828 is a distinct investigational drug developed by Eli Lilly and Company. No alternative names have been reported for this compound. It is being studied as a small molecule in Phase 1 trials for healthy participants.