Phase 1
Completed N=53
A Study of LY3451838 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03692949 ↗
Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Number of Participants With Any Treatment Emergent Adverse Event — 4; 5; 4; 6 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Treatment Emergent Adverse Event |
4; 5; 4; 6; 4; 5 | — |
| PRIMARY Number of Participants With One or More Serious Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838 |
1580; 7510; 21900; 46100; 85500; 128000 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838 |
8.54; 30.9; 89.1; 172; 318; 523 | — |
Eligibility Criteria
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currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study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
Data sourced from ClinicalTrials.gov (NCT03692949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.