A Study of Two Different Formulations of LY3074828 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: LY3074828

• Registration Number: NCT03188510
• Lead Sponsor: Eli Lilly and Company

Brief 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 total duration of the clinical trial will be approximately 13 weeks, not including screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Study Start: 2017-06-30
• Primary Completion: 2017-11-27
• Study Completion: 2017-11-27
• Status Verified: 2023-05
• Results First Submitted: 2023-05-05
• Results First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Results First Posted: 2024-01-25
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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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 1 month 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 sever 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test 2: 500 mg LY3074828	LY3074828	500 mg LY3074828 solution formulation administered as SC injections in four prefilled syringes
Reference: 250 mg LY3074828	LY3074828	250 mg LY3074828 lyophilized formulation administered subcutaneously (SC) as 3 injections
Test 1: 250 mg LY3074828	LY3074828	250 mg LY3074828 solution formulation administered as SC injections in two prefilled syringes

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828	Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose	PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC\[0-tlast\]) of LY3074828 was evaluated. Unit of measure expansion: microgram\*day per milliliter per milligram (µg\*day/mL/mg).
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828	Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose	PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC\[0-∞\]) of LY3074828 was evaluated.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)	Predose Day 1 Through Day 85	Number of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted).

Trial Locations

Locations (1)

Covance; 🇺🇸 Dallas, Texas, United States