A Study of Two Formulations of LY3074828 in Healthy Participants

Healthy Clinical Trial

Official title:

A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 2-mL Autoinjector in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662100
• Other study ID #: 16618
• Secondary ID: I6T-MC-AMAR
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: May 1, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: Healthy participants.

Exclusion Criteria:

• Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
• Must not show evidence of active or latent tuberculosis (TB)
• Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
• Must not have been treated with steroids within 1 month of screening, or intend to during the study
• Must not be immunocompromised
• Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
• Must not have significant allergies to humanised monoclonal antibodies
• Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
• Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• Must not have had breast cancer within the past 10 years

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• LY3074828
Administered SC

Drug:
• LY3074828
Administered SC

Device:
• Auto-injector (AI)
AI to administer LY3074828
• Prefilled syringe (PFS)
PFS to administer LY3074828

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device	Pharmacokinetics: Cmax of LY3074828	Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Primary	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-8)) of LY3074828 by Device	Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-8)) of LY3074828	Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Primary	Visual Analogue Scale (VAS) Pain Assessment by Device	The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.	Day 1: 1, 5 (±1.5) and 15 (±2) minutes
Primary	Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location	The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.	Day 1: 1, 5 (±1.5) and 15 (±2) minutes