A Safety Study of LY3462817 in Healthy Participants

NCT03715192 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17089J1A-MC-KDAB
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through to final follow-up at approximately Week 12

Secondary Outcomes (2)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817

  Baseline through to final follow-up at approximately Week 12

• Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3462817

  Baseline through to final follow-up at approximately Week 12

Study Arms (3)

LY3462817 - IV

EXPERIMENTAL

Escalating doses of LY3462817 administered as a single intravenous (IV) infusion in healthy participants

Biological: LY3462817 IV

Placebo

PLACEBO COMPARATOR

Normal saline administered as a single IV infusion in healthy participants

Drug: Placebo

LY3462817 - SC

EXPERIMENTAL

Single dose of LY3462817 administered as subcutaneous (SC) injections in healthy participants

Biological: LY3462817 SC

Interventions

LY3462817 IV BIOLOGICAL

Administered IV

LY3462817 - IV

LY3462817 SC BIOLOGICAL

Administered SC

LY3462817 - SC

Placebo DRUG

Administered IV

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy male or a female who cannot get pregnant
• Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
• Weight at least 45 kilograms (kg)

You may not qualify if:

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have cancer or a malignant disease in the past 5 years
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Are unwilling to receive study drug administration by injections or through the veins

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Nus Centre for Clin Pharmacology

Singapore, 138623, Singapore

Location

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

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: October 19, 2018
• First Posted: October 23, 2018
• Study Start: December 13, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)