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OpenTrials
Completed

NCT Number: NCT03692949

A Study of LY3451838 in Healthy Participants

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).

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Key information

Conditions

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study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

Treatment and study plan

LY3451838

Drug

Administered IV Part A

Placebo

Drug

Administered IV in Part A and SC in Part B

Primary outcomes

  1. Number of Participants With Any Treatment Emergent Adverse Event

    Time frame: 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.

  2. Number of Participants With One or More Serious Adverse Events

    Time frame: 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 outcomes

  1. Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838

    Time frame: 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

  2. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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