A Study of Two Formulations of Ixekizumab in Healthy Participants

Phase 1 Completed 245 enrolled Eli Lilly and Company

RandomizedParallel-groupSingle-blindBasic science

Summary

The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Information about any side effects that may occur will also be collected. The study will last up to about four months for each participant.

Timeline

Start: 2020-02-05
Primary completion: 2021-02-19
Completion: 2021-02-19

Outcome

Met primary endpoint

paper In study B, bioequivalence of the CF formulation was established as 90% CIs for the ratio of geometric LSM AUC0-tlast, AUC0-∞, and Cmax between treatments were contained within the prespecified limits of 0.8 and 1.25. PMID 35449322 ↗

Publications

Chabra S, Gill BJ, Gallo G, Zhu D, Pitou C, Payne CD, Accioly A, Puig L. Ixekizumab Citrate-Free Formulation: Results from Two Clinical Trials. Adv Ther. 2022 Jun;39(6):2862-2872. doi: 10.1007/s12325-022-02126-0. Epub 2022 Apr 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixekizumab	Monoclonal antibody	80 mg	Subcutaneous

Indications

No indication recorded.