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OpenTrials
Completed

NCT Number: NCT03715192

A Safety Study of LY3462817 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Nus Centre for Clin Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

LY3462817 IV

Biological

Administered IV

LY3462817 SC

Biological

Administered SC

Placebo

Drug

Administered IV

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

    Time frame: 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 outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817

    Time frame: Baseline through to final follow-up at approximately Week 12

    Pharmacokinetics: Cmax of LY3462817

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

    Time frame: Baseline through to final follow-up at approximately Week 12

    Pharmacokinetics: AUC of LY3462817

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3462817

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2018
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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