A Study of LY3451838 in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: LY3451838
Drug: Placebo

Registration Number: NCT03692949

Lead Sponsor: Eli Lilly and Company

Brief Summary: The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

Inclusion Criteria

Male participants must adhere to contraception restrictions
Female participants must be of non-childbearing potential due to:
- Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
- Surgical sterilization
Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
Have clinical laboratory test results within normal reference range or with acceptable deviations
Have an estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute per 1.73 meters squared (mL/minute/1.73 m²) of body surface area
Have venous access sufficient to allow for blood sampling

Exclusion Criteria

Are currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study
Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality
Have history of or presence of uncontrolled asthma, significant atopy, or significant rheumatological or autoimmune diseases
Have had lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years (with some exceptions)
Have used, or intend to use some prescription or over the counter medications, including herbal medications within 14 days prior to dosing
Have an abnormality in the 12-lead electrocardiogram (ECG) or Fridericia's corrected QT (QTcF)
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen
Have donated blood of more than 450 milliliters (mL) within the last 3 months
Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit (CRU)
Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
Current smoker of more than 10 cigarettes or equivalent per day and unable to stop smoking while in the CRU
Have an abnormal blood pressure
Have clinically significant proteinuria or hematuria
Positive findings for known drugs of abuse
Have received treatment with biologic agents within 3 months or 5 half-lives (whichever is longer)
Have clinically significant allergies, or intolerance to corticosteroids, or severe post treatment hypersensitivity reactions

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 milligram (mg) LY3451838 Part A	LY3451838	25 mg LY3451838 single dose administered intravenously (IV)
75 mg LY3451838 Part A	LY3451838	75 mg LY3451838 single dose administered IV.
250 mg LY3451838 Part A	LY3451838	250 mg LY3451838 single dose administered IV.
500 mg LY3451838 Part A	LY3451838	500 mg LY3451838 single dose administered IV.
1000 mg LY3451838 Part A	LY3451838	1000 mg LY3451838 single dose administered IV.
1500 mg LY3451838 Part A	LY3451838	1500 mg LY3451838 single dose administered IV.
250 mg LY3451838 Part B	LY3451838	250 mg LY3451838 single dose administered subcutaneously (SC).
Placebo	Placebo	Placebo matching single dose administered IV in Part A or administered SC in Part B.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Any Treatment Emergent Adverse Event	Baseline through 20 Weeks	A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Number of Participants With One or More Serious Adverse Events	Baseline through 20 Weeks	A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838	Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose	PK: AUC of LY3451838
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838	Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose	PK: Cmax of LY3451838