A Study of LY3025876 in Healthy Volunteers

NCT01528124 | Completed Phase 1 Results

• 2 other identifiers: 14346I6D-FW-SMRA
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events

  Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.

  Baseline up to 28 days post-dose

Secondary Outcomes (3)

• Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose

• Number of Participants Developing Anti-LY3025876 Antibodies

  Day 28 post-dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride given as a single subcutaneous injection

Drug: Placebo

LY3025876

EXPERIMENTAL

Single escalating doses of LY3025876 given as subcutaneous injections

Drug: LY3025876

Interventions

LY3025876 DRUG

Given as a subcutaneous injection

LY3025876

Placebo DRUG

Given as a subcutaneous injection

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be either a healthy male or a healthy female who cannot become pregnant
• Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m\^2), inclusive, at screening

You may not qualify if:

• Are allergic to LY3025876 or related compounds
• Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication
• Have a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids. Corticosteroids are mainly used to control inflammation.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, 117597, Singapore

Location

Results Point of Contact

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

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: Yes

Study Design

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

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 16, 2018
• Results First Posted: July 16, 2018

Record last verified: 2017-09

Locations

SG (1)