A Study of LY3451838 in Healthy Participants

NCT03692949 | Completed Phase 1 Results

• 2 other identifiers: 17123J1H-MC-LAJA
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Any Treatment Emergent Adverse Event

  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.

  Baseline through 20 Weeks

• Number of Participants With One or More Serious Adverse Events

  A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

  Baseline through 20 Weeks

Secondary Outcomes (2)

• 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

• 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

Study Arms (8)

25 milligram (mg) LY3451838 Part A

EXPERIMENTAL

25 mg LY3451838 single dose administered intravenously (IV)

Drug: LY3451838

75 mg LY3451838 Part A

EXPERIMENTAL

75 mg LY3451838 single dose administered IV.

Drug: LY3451838

250 mg LY3451838 Part A

EXPERIMENTAL

250 mg LY3451838 single dose administered IV.

Drug: LY3451838

500 mg LY3451838 Part A

EXPERIMENTAL

500 mg LY3451838 single dose administered IV.

Drug: LY3451838

1000 mg LY3451838 Part A

EXPERIMENTAL

1000 mg LY3451838 single dose administered IV.

Drug: LY3451838

1500 mg LY3451838 Part A

EXPERIMENTAL

1500 mg LY3451838 single dose administered IV.

Drug: LY3451838

250 mg LY3451838 Part B

EXPERIMENTAL

250 mg LY3451838 single dose administered subcutaneously (SC).

Drug: LY3451838

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3451838 DRUG

Administered IV Part A

25 milligram (mg) LY3451838 Part A

Placebo DRUG

Administered IV in Part A and SC in Part B

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Publications (1)

• Johnson MP, Krikke-Workel J, Patel CN, Morin SM, Turner PK, Clark KA, Donley D, Jin Y, Johnson KW, Vincent M, Stille JR, Broad LM, Patel A. Preclinical and clinical evaluation of LY3451838, a PACAP-neutralizing monoclonal antibody, in randomized, double-blind, placebo-controlled phase 1 and phase 2 studies involving healthy adults and adults with treatment-resistant migraine. Cephalalgia. 2025 Aug;45(8):3331024251368757. doi: 10.1177/03331024251368757. Epub 2025 Aug 21.

  PMID: 40836866 DERIVED

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 2, 2018
• Study Start: December 11, 2018
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-09-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)