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NCT04259346 · ClinicalTrials.gov registry record · Phase 1

A Study of Two Formulations of Ixekizumab in Healthy Participants

A Phase 1 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
245
Enrollment target

NCT04259346: Completed Phase 1 study, sponsored by Eli Lilly and Company.

NCT04259346 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 245 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (308% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04259346, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
245 participants
Enrollment target

Study 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.

Primary Outcome

PK: Cmax of ixekizumab was evaluated

Interventions

  • DRUG Ixekizumab

Trial Details

FieldValue
Enrollment Target 245 participants
Start Date 2020-02-05
Est. Completion 2021-02-19
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the finished NCT04259346 record still lists

NCT04259346 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (308% higher).

The record links to 0 conditions, and to 1 intervention - of which Ixekizumab is the first listed.

NCT04259346 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04259346 about?

NCT04259346 is a clinical study titled "A Study of Two Formulations of Ixekizumab in Healthy Participants". 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...

What is the current status of trial NCT04259346?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 245 participants. The study started on 2020-02-05. Estimated completion is 2021-02-19.

What interventions are being tested in trial NCT04259346?

The interventions under investigation include: Ixekizumab (DRUG).

Who is sponsoring clinical trial NCT04259346?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04259346's enrollment target sits among peer trials

245 189th of 2000 higher than 1,810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04259346, the US trial registry maintained by the National Library of Medicine. NCT04259346 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.