NCT04259346

A Study of Two Formulations of Ixekizumab in Healthy Participants

Completed Phase 1 Results posted Last updated 8 April 2022

What this trial tests

Phase 1 trial testing Ixekizumab in Healthy in 245 participants. Completed in 19 February 2021.

Timeline

5 February 2020

Primary endpoint
19 February 2021

19 February 2021

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	245
Start date	5 February 2020
Primary completion	19 February 2021
Estimated completion	19 February 2021
Sites	4 locations across United States

Drugs / interventions tested

• Ixekizumab (ixekizumab) — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab Primary · Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose

PK: Cmax of ixekizumab was evaluated

Group	Value	95% CI
80 mg Ixekizumab (Reference)	9.66	± 33
80 mg Ixekizumab (Test)	9.97	± 35

PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab Primary · Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose

Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.

Group	Value	95% CI
80 mg Ixekizumab (Reference)	207	± 31
80 mg Ixekizumab (Test)	219	± 28

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab Primary · Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose

Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab.

Group	Value	95% CI
80 mg Ixekizumab (Reference)	213	± 33
80 mg Ixekizumab (Test)	227	± 30

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 85 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

80 mg Ixekizumab (Reference)

Serious: 0/126 (0%)

Deaths: 0/126

80 mg Ixekizumab (Test)

Serious: 0/119 (0%)

Deaths: 0/119

Other adverse events (2 terms — click to expand)

Reaction	System	80 mg Ixekizumab (Reference)	80 mg Ixekizumab (Test)
Injection site reaction	General disorders	—	—
Headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT04259346 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ixekizumab Citrate-Free Formulation: Results from Two Clinical Trials.
   Chabra S, Gill BJ, Gallo G, Zhu D, et al · · 2022 · cited 23× · PMID 35449322 · DOI 10.1007/s12325-022-02126-0