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Also known as Citrate-Free Mirikizumab
Free Mirikizumab · 1 trial · 1 indication
Cmax of Mirikizumab is reported.
AUC \[0-∞\] of Mirikizumab is reported.
AUC \[0 to tlast\] of Mirikizumab is reported.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Citrate-Free Mirikizumab | DRUG | Administered SC |
Inclusion Criteria: Type of participant and disease characteristics 1. Overtly healthy males and females as determined by medical evaluation including: * Medical history, * Physical examination, * Clinical laboratory tests, * Electrocardiogram (ECG), * Vital signs Note: partici...
Citrate-free mirikizumab, also called free mirikizumab, is an investigational monoclonal antibody developed by Eli Lilly and Company under the code LY3074828. It is a citrate-free formulation studied in healthy adult participants. The specific therapeutic indications for this formulation have not been disclosed.
Citrate-free mirikizumab is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating this citrate-free formulation of the monoclonal antibody.
Citrate-free mirikizumab is in Phase 1 development. It is an investigational product and is not approved by the FDA. The Phase 1 program consists of one completed trial, a bioequivalence study conducted in healthy participants.
Citrate-free mirikizumab has been studied in one Phase 1 trial, NCT06475729, titled A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants. The trial enrolled 498 participants in the United States, was randomized and controlled, and has been completed.
Citrate-free mirikizumab, also known as free mirikizumab, is a citrate-free formulation of the monoclonal antibody mirikizumab, which Lilly codes as LY3074828. The citrate-free version was developed as a separate formulation and was evaluated in a dedicated Phase 1 bioequivalence study in healthy participants.
Citrate-free mirikizumab is an investigational monoclonal antibody studied in healthy adult participants in a Phase 1 bioequivalence trial. Its therapeutic indications have not been disclosed. It is not an approved product, and its clinical development remains at the Phase 1 stage.