A Safety Study of LY3462817 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715192
• Other study ID #: 17089
• Secondary ID: J1A-MC-KDAB
• Status: Completed
• Phase: Phase 1
• Start date: December 13, 2018
• Est. completion date: December 11, 2019

Study information

• Verified date: December 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• LY3462817 IV
Administered IV
• LY3462817 SC
Administered SC

Drug:
• Placebo
Administered IV

Locations

Country	Name	City	State
Singapore	Lilly Nus Centre for Clin Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817	Pharmacokinetics: Cmax of LY3462817	Baseline through to final follow-up at approximately Week 12
Secondary	Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3462817	Pharmacokinetics: AUC of LY3462817	Baseline through to final follow-up at approximately Week 12