A Study of LY3053102 in Healthy Participants

NCT01736241 | Completed Phase 1 Results

• 2 other identifiers: 14514I6I-MC-LMRA
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs

  A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Baseline through Day 31

Secondary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102

  Time 0 to 168 hours after study drug administration on Day 1

• PK: Observed Maximum Drug Concentration (Cmax) of LY3053102

  Time 0 to 168 hours after study drug administration on Day 1

• Number of Participants Who Developed Anti-LY3053102 Antibodies

  Baseline, up to Day 31

Study Arms (2)

LY3053102

EXPERIMENTAL

A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level.

Drug: LY3053102

Placebo

PLACEBO COMPARATOR

A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks.

Drug: Placebo

Interventions

LY3053102 DRUG

LY3053102

Placebo DRUG

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:

• Normal blood pressure
• Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
• Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m\^2), inclusive, at screening

You may not qualify if:

• Had known allergies to LY3053102 or related compounds
• Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
• Had 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
• Heavy smokers (more than 10 cigarettes a day)

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: No
• Restriction Type: GT60
• Restrictive Agreement: 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: November 26, 2012
• First Posted: November 29, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 19, 2018
• Results First Posted: July 19, 2018

Record last verified: 2017-09

Locations

SG (1)