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

Study Timeline

• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Study Start: 2018-12-11
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2020-03-01
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

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

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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currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3451838 Part A	LY3451838	Single ascending doses, administered intravenously (IV)
Placebo Part A	Placebo	Matching single doses administered intravenously (IV)
LY3451838 Part B	LY3451838	Single doses administered subcutaneously (SC)
Placebo Part B	Placebo	Matching single doses administered subcutaneously (SC)

Primary Outcome Measures

Name	Time	Method
Number of Participants with any Treatment Emergent Adverse Event	Baseline through twenty weeks	Serious and other non-serious adverse events will be reported in the Adverse Events Module
Number of Participants with One or More Serious Adverse Events	Baseline through twenty weeks	Serious and other non-serious adverse events will be reported in the Adverse Events Module

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve (AUC) of LY3451838	Pre-dose through twenty weeks	Pharmacokinetics (PK): AUC of LY3451838
Maximum Concentration (Cmax) of LY3451838	Pre-dose through twenty weeks	PK: Cmax of LY3451838

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore