Study of Ixekizumab in Healthy Participants

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Biological: Ixekizumab

• Registration Number: NCT03848403
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions \[ISRs\]) will be collected.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-29
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Primary Completion: 2019-07-18
• Study Completion: 2019-07-18
• Results First Submitted: 2020-07-16
• Results First Submitted QC: 2020-07-16
• Results First Posted: 2020-07-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Healthy male participants or female participants who agree not to get pregnant
• Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study

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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
• Have dullness or loss of sensitivity on either side of your abdomen
• Have any condition that could affect pain perception from an injection
• 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 excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments
• 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 if participating in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ixekizumab (Test 1)	Ixekizumab	Test 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
Ixekizumab (Test 2)	Ixekizumab	Test 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
Ixekizumab (Reference)	Ixekizumab	Reference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.

Primary Outcome Measures

Name	Time	Method
Injection Pain Visual Analog Scale (VAS) Score	Day 1, 8, and 15: Immediately (within 1 minute) after injection	The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (\>30 and ≤70), and severe pain (\>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).

Trial Locations

Locations (2)

Covance; 🇺🇸 Dallas, Texas, United States

Covance Clinical Research Inc; 🇺🇸 Madison, Wisconsin, United States