Phase 1
Completed N=245
A Study of Two Formulations of Ixekizumab in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04259346 ↗
Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab — 9.66; 9.97 micrograms per milliliter (ug/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab |
9.66; 9.97 | — |
| PRIMARY PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab |
207; 219 | — |
| PRIMARY PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab |
213; 227 | — |
Eligibility Criteria
Inclusion Criteria
- Are healthy male or female participants, with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study
Exclusion Criteria
- Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
- Are allergic or hypersensitive to the study medicine
- Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
- Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
- Show evidence of active or latent tuberculosis (TB)
- Presence of significant neuropsychiatric disorder or a recent history of depression
- Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator, would pose an unacceptable risk to the participant
Data sourced from ClinicalTrials.gov (NCT04259346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.