A Study of LY3451838 in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: LY3451838

Study type

Interventional

Funder types

Industry

Identifiers

NCT03692949

17123

J1H-MC-LAJA (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

53 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

53 participants in 8 patient groups, including a placebo group

25 milligram (mg) LY3451838 Part A

Experimental group

Description:

25 mg LY3451838 single dose administered intravenously (IV)

Treatment:

Drug: LY3451838

75 mg LY3451838 Part A

Experimental group

Description:

75 mg LY3451838 single dose administered IV.

Treatment:

Drug: LY3451838

250 mg LY3451838 Part A

Experimental group

Description:

250 mg LY3451838 single dose administered IV.

Treatment:

Drug: LY3451838

500 mg LY3451838 Part A

Experimental group

Description:

500 mg LY3451838 single dose administered IV.

Treatment:

Drug: LY3451838

1000 mg LY3451838 Part A

Experimental group

Description:

1000 mg LY3451838 single dose administered IV.

Treatment:

Drug: LY3451838

1500 mg LY3451838 Part A

Experimental group

Description:

1500 mg LY3451838 single dose administered IV.

Treatment:

Drug: LY3451838

250 mg LY3451838 Part B

Experimental group

Description:

250 mg LY3451838 single dose administered subcutaneously (SC).

Treatment:

Drug: LY3451838

Placebo

Placebo Comparator group

Description:

Placebo matching single dose administered IV in Part A or administered SC in Part B.

Treatment:

Drug: Placebo

Trial documents

2

Trial contacts and locations

1

Loading...