A Safety Study of LY3462817 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: LY3462817 IV; Drug: Placebo; Biological: LY3462817 SC

• Registration Number: NCT03715192
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Study Start: 2018-12-13
• Status Verified: 2019-12
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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)

Read More

Exclusion Criteria

• 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• Have previously participated or withdrawn from this study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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3462817 - IV	LY3462817 IV	Escalating doses of LY3462817 administered as a single intravenous (IV) infusion in healthy participants
Placebo	Placebo	Normal saline administered as a single IV infusion in healthy participants
LY3462817 - SC	LY3462817 SC	Single dose of LY3462817 administered as subcutaneous (SC) injections in healthy participants

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	Baseline through to final follow-up at approximately Week 12	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3462817	Baseline through to final follow-up at approximately Week 12	Pharmacokinetics: AUC of LY3462817
Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817	Baseline through to final follow-up at approximately Week 12	Pharmacokinetics: Cmax of LY3462817

Trial Locations

Locations (1)

Lilly Nus Centre for Clin Pharmacology; 🇸🇬 Singapore, Singapore