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A Safety Study of LY3462817 in Healthy Participants

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03715192
Enrollment
64
Registered
2018-10-23
Start date
2018-12-13
Completion date
2019-12-11
Last updated
2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

BIOLOGICALLY3462817 IV

Administered IV

BIOLOGICALLY3462817 SC

Administered SC

DRUGPlacebo

Administered IV

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes

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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have cancer or a malignant disease in the past 5 years * Have or used to have health problems or laboratory test results or ECG readings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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817Baseline through to final follow-up at approximately Week 12Pharmacokinetics: Cmax of LY3462817
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3462817Baseline through to final follow-up at approximately Week 12Pharmacokinetics: AUC of LY3462817

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026