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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBV | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab (Reference) | Experimental | 200 milligram (mg) of mirikizumab as reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe 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 pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Reference and test formulations of mirikizumab administered as a SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | PK: Cmax of mirikizumab was evaluated. | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Mirikizumab | PK: AUC(0-inf) of mirikizumab was evaluated. | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to t, Where t is the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab | PK: (AUC[0-tlast]) of mirikizumab was evaluated. | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS | Springfield | Missouri | 65802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40117091 | Derived | Otani Y, Feagan BG, D'Haens GR, Escobar R, Morris NJ, Payne CD, Ugolini Lopes M, Zhang X. Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials. Adv Ther. 2025 May;42(5):2369-2384. doi: 10.1007/s12325-025-03158-y. Epub 2025 Mar 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 Milligram (mg) Mirikizumab (Reference): Arm | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a subcutaneous (SC) injection into the arm on day 1. |
| FG001 | 200 mg Mirikizumab (Reference): Thigh | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the thigh on day 1. |
| FG002 | 200 mg Mirikizumab (Reference): Abdomen | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the abdomen on day 1. |
| FG003 | 200 mg Mirikizumab (Test): Arm | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm on day 1. |
| FG004 | 200 mg Mirikizumab (Test): Thigh | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the thigh on day 1. |
| FG005 | 200 mg Mirikizumab (Test): Abdomen | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the abdomen on day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg Mirikizumab (Reference) | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1. |
| BG001 | 200 mg Mirikizumab (Test) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | PK: Cmax of mirikizumab was evaluated. | All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose |
|
Up To 85 Days
All participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200 mg Mirikizumab (Reference): Arm | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 17, 2020 | Dec 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2020 | Dec 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Mirikizumab | PK: AUC(0-inf) of mirikizumab was evaluated. | All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*day/mL | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose |
|
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to t, Where t is the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab | PK: (AUC[0-tlast]) of mirikizumab was evaluated. | All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*day/mL | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 200 mg Mirikizumab (Reference): Thigh | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the thigh on day 1. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG002 | 200 mg Mirikizumab (Reference): Abdomen | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the abdomen on day 1. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG003 | 200 mg Mirikizumab (Test): Arm | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm on day 1. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | 200 mg Mirikizumab (Test): Thigh | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the thigh on day 1. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG005 | 200 mg Mirikizumab (Test): Abdomen | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the abdomen on day 1. | 0 | 10 | 0 | 10 | 3 | 10 |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Anosmia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
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