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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07446101 | A Study of Mirikizumab Solution (LY3074828) in Healthy Participants | PHASE1 | RECRUITING | 450 | — | — | Mar 24, 2026 | Feb 1, 2027 | May 14, 2026 | 5 | United States |
| NCT05644353 | A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants | PHASE1 | COMPLETED | 450 | — | — | Dec 5, 2022 | May 25, 2023 | Mar 28, 2025 | 6 | United States |
| NCT05515601 | A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants | PHASE1 | COMPLETED | 396 | — | — | Aug 31, 2022 | Feb 20, 2023 | Jul 5, 2024 | 6 | United States |
| NCT05069896 | A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants | PHASE1 | COMPLETED | 237 | — | — | Oct 5, 2021 | Jun 22, 2022 | Mar 4, 2025 | 3 | United States |
| NCT04607733 | A Study of Mirikizumab in Healthy Participants | PHASE1 | COMPLETED | 240 | — | — | Nov 2, 2020 | May 17, 2021 | Feb 20, 2024 | 4 | United States |
| NCT04548219 | A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants | PHASE1 | COMPLETED | 60 | — | — | Sep 11, 2020 | Jan 11, 2021 | Jan 25, 2024 | 1 | United States |
| NCT04137380 | A Study of Mirikizumab in Healthy Chinese Participants | PHASE1 | COMPLETED | 60 | — | — | Dec 4, 2019 | Dec 11, 2020 | Jan 26, 2024 | 2 | China |
| NCT03053622 | A Study of Mirikizumab (LY3074828) Injection in Healthy Participants | PHASE1 | COMPLETED | 67 | — | — | Apr 24, 2017 | Apr 3, 2018 | Feb 21, 2024 | 1 | United Kingdom |
| NCT02568423 | A Study of Mirikizumab (LY3074828) in Healthy Participants | PHASE1 | COMPLETED | 51 | — | — | Dec 2, 2015 | Oct 24, 2018 | Feb 8, 2024 | 1 | United States |
PK: Cmax of Mirikizumab
PK: AUC\[0-∞\] of Mirikizumab
PK: AUC\[0-tlast\] of Mirikizumab
PK: Cmax of mirikizumab was evaluated.
PK: AUC\[0-∞\] of Mirikizumab was evaluated.
PK: AUC\[0-tlast\] of Mirikizumab was evaluated.
PK: Cmax of Mirikizumab administered by PFS and AI.
PK: AUC\[0-∞\] of Mirikizumab administered by PFS and AI.
PK: AUC\[0-tlast\] of Mirikizumab administered by PFS and AI.
PK: AUC\[0-∞\] of Mirikizumab
PK: AUC\[0-tlast\] of Mirikizumab
PK: AUC(0-inf) of mirikizumab was evaluated.
PK: (AUC\[0-tlast\]) of mirikizumab was evaluated.
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (\>30 and ≤70), and severe pain (\>70). 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 (worst imaginable pain).
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC\[0-∞\]) of Mirikizumab
SAE is any adverse event (AE) from this study that results in one of the following outcomes: 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. considered significant by the investigator for any other reason
| Arm | Type | Description |
|---|---|---|
| Mirikizumab (Test Arm 1) | EXPERIMENTAL | Mirikizumab administered subcutaneously (SC) |
| Mirikizumab (Test Arm 2) | EXPERIMENTAL | Mirikizumab administered SC |
| Mirikizumab (Reference Arm) | EXPERIMENTAL | Mirikizumab administered SC |
| Mirikizumab | EXPERIMENTAL | Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via Pre-filled Syringe (PFS) to abdomen or arms or thighs on Day 1. |
| Citrate-Free Mirikizumab | EXPERIMENTAL | Participants received 3 mL citrate- free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1. |
| Mirikizumab (Reference) | EXPERIMENTAL | 200 milligram (mg) of mirikizumab as reference formulation \[100 mg/milliliter (mL)\], 2 × 1-mL autoinjector administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1. |
| Mirikizumab (Test) | EXPERIMENTAL | 200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1. |
| Mirikizumab - Prefilled Syringe | EXPERIMENTAL | Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via a prefilled syringe (PFS) to abdomen or arms or thighs. |
| Mirikizumab - Autoinjector | EXPERIMENTAL | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered an autoinjector (AI) to abdomen or arms or thighs. |
| Mirikizumab - Intravenous (IV) | EXPERIMENTAL | Participants received a single dose of 300 milligram (mg), 600 mg and 1200 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes, 60 minutes and 2 hours. |
| Placebo - IV | PLACEBO_COMPARATOR | Participants received a single dose of placebo administered IV using a forearm vein. |
| Mirikizumab - Subcutaneous (SC) | EXPERIMENTAL | Participants received a single dose of 200 mg, 400 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| Placebo - SC | PLACEBO_COMPARATOR | Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| Mirikizumab Test Subcutaneous (SC) 1 | EXPERIMENTAL | 250 mg mirikizumab test formulation given as a single injection SC in healthy participants |
| Mirikizumab Test SC 2 | EXPERIMENTAL | 250 mg mirikizumab test formulation given as two injections given SC in healthy participants |
| Mirikizumab Test Intravenous (IV) | EXPERIMENTAL | 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants |
| Mirikizumab Reference | ACTIVE_COMPARATOR | 250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants |
| Mirikizumab IV | EXPERIMENTAL | Participants received 200mg Mirikizumab by intravenously. |
| Mirikizumab SC | EXPERIMENTAL | Participants received single dose of either 60mgor 200mg 0r 600mg or 1200mg or 2400mg Mirikizumab by subcutaneously. |
| Placebo IV | PLACEBO_COMPARATOR | Participants received placebo by intravenously. |
| Placebo SC | PLACEBO_COMPARATOR | Participants received placebo by subcutaneously. |
| Name | Type | Description |
|---|---|---|
| Mirikizumab | DRUG | Administered SC |
| Mirikizumab Prefilled Syringe | DRUG | Administered SC by prefilled syringe |
| Mirikizumab Autoinjector | DRUG | Administered SC by autoinjector |
| Mirikizumab - IV | DRUG | Administered IV |
| Mirikizumab - SC | DRUG | Administered SC |
| Placebo - IV | DRUG | Administered IV |
| Placebo - SC | DRUG | Administered SC |
| Mirikizumab Test | BIOLOGICAL | Administered SC |
| Mirikizumab Reference | BIOLOGICAL | Administered SC |
Inclusion Criteria: * Are overtly healthy males or females as determined by medical evaluation including: * medical history * physical examination * clinical laboratory tests * ECG, and * vital signs. * Have clinical laboratory test results at screening and Day -1 within normal reference...