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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMCB | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector.
Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg Mirikizumab (Test) | Experimental | Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. |
|
| 200 mg Mirikizumab (Reference) | Experimental | Participants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrate-Free Mirikizumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | Cmax of Mirikizumab is reported. | Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab | AUC [0-∞] of Mirikizumab is reported. | Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. |
| PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab | AUC [0 to tlast] of Mirikizumab is reported. | Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. |
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Inclusion Criteria:
Type of participant and disease characteristics
Overtly healthy males and females as determined by medical evaluation including:
Note: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.
Have clinical laboratory test results:
Weight
Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m^2), inclusive.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation.
Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
Have a diagnosis or history of malignant disease within 5 years prior to baseline.
Prior/concomitant therapy
Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing.
Have received treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing.
Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use.
Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before randomization.
Prior/concurrent clinical study experience
Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing.
Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab.
Diagnostic assessments
Have a current infection with hepatitis C virus.
Have a current infection with hepatitis B virus.
Have a current or recent acute, active infection.
Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization:
Show evidence of active or latent tuberculosis (TB).
Other exclusion criteria
Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
Smoke more than 10 cigarettes per day, or equivalent, or are unable to abide by investigative site smoking restrictions.
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
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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 |
|---|---|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | United States | ||
| Fortrea Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41313544 | Derived | Otani Y, Payne CD, Loftus EV Jr, D'Haens G, Ben Horin S, Upadhya K A, Todd K, Pellanda P, Shi G, Zhang X. One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants. Adv Ther. 2026 Jan;43(1):377-389. doi: 10.1007/s12325-025-03422-1. Epub 2025 Nov 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 mg Mirikizumab (Reference) | Participants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. |
| FG001 | 200 mg Mirikizumab (Test) | Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who were exposed to study intervention (Safety Population).
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg Mirikizumab (Reference) | Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into 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, Continuous | Mean |
| 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 Observed Drug Concentration (Cmax) of Mirikizumab | Cmax of Mirikizumab is reported. | All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (ug/mL) | Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. |
|
Baseline up to Day 74
All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
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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) | Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | 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 | Sep 24, 2024 | Dec 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2024 | Dec 3, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Daytona Beach |
| Florida |
| 32117 |
| United States |
| Clinical Pharmacology of Miami | Miami | Florida | 33014-3616 | United States |
| QPS Missouri | Springfield | Missouri | 65802 | United States |
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
| Fortrea Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Adverse Event |
|
Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab | AUC [0-∞] of Mirikizumab is reported. | All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (ug*day/mL) | Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. |
|
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab | AUC [0 to tlast] of Mirikizumab is reported. | All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (ug*day/mL) | Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. |
|
|
|
|
| 0 |
| 240 |
| 0 |
| 240 |
| 55 |
| 240 |
| EG001 | 200 mg Mirikizumab (Test) | Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. | 0 | 244 | 0 | 244 | 48 | 244 |
| Palpitations | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Sars-cov-2 test positive | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
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