A Study of LY3461767 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3461767 - IV; Drug: LY3461767 - SC; Drug: Placebo - SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04352114

17517

J2L-MC-EZBA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.

Enrollment: 48 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are healthy males, or females of non-child-bearing potential
• Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
• Have clinical laboratory tests within normal ranges as judged by investigator
• Have pulse rate and blood pressure within normal ranges as judged by investigator

Exclusion criteria

• Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
• Regularly use known drugs of abuse
• Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
• Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
• Smoke more than 10 cigarettes per day
• Are current or former smokers with 30-pack-year smoking history
• Have a diagnosis or history of any malignancy
• Have not had appropriate cancer screening, in accordance with country specific guidance

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

LY3461767 - Subcutaneous (SC)

Experimental group

Description:

LY3461767 administered SC.

Treatment:

Drug: LY3461767 - SC

Placebo - SC

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo - SC

LY3461767 - Intravenous (IV)

Experimental group

Description:

LY3461767 administered IV.

Treatment:

Drug: LY3461767 - IV