A Study of Ixekizumab in Healthy Participants

NCT03848416 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17140I1F-MC-RHCT
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab

  Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab

  Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose

• PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab

  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.

  Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose

• PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab.

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

  Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose

Study Arms (3)

Ixekizumab (Reference)

EXPERIMENTAL

Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe.

Biological: Ixekizumab

Ixekizumab (Test 1)

EXPERIMENTAL

Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.

Biological: Ixekizumab

Ixekizumab (Test 2)

EXPERIMENTAL

Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.

Biological: Ixekizumab

Interventions

Ixekizumab BIOLOGICAL

Administered SC

Also known as: LY2439821

Ixekizumab (Reference); Ixekizumab (Test 1); Ixekizumab (Test 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male participant or female participant who agree to not become pregnant
• Are male participant 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

You may not qualify if:

• 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, if participating in the study

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

ixekizumab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: January 29, 2019
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: June 24, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)