Study of LY3074828 in Healthy Participants

Healthy Clinical Trial

Official title:

A Study to Investigate the Tolerability of Subcutaneous Injections of LY3074828 Compared to Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748940
• Other study ID #: 17097
• Secondary ID: I9O-MC-AABC2018-
• Status: Completed
• Phase: Phase 1
• Start date: October 10, 2018
• Est. completion date: June 18, 2019

Study information

• Verified date: July 2019
• 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 evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").

The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have venous access sufficient to allow for blood sampling and administration of investigational product

Exclusion Criteria:

• Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per 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 receive during the study

• Must not be immunocompromised

• Must not have known hypersensitivity to hyaluronidases

• 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 dosing

• Must not have significant allergies to humanized monoclonal antibodies

• Must not have clinically significant multiple or severe drug allergies, 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

Drug:
• LY3074828
Administered SC
• Placebo
Administered SC
• LY900021
Administered SC

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Ltd	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Pain Score	The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).	Within 1-minute post injection