A Study of Ramucirumab (LY3009806) in Healthy Participants

NCT04495478 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17748I4T-MC-JVDT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a new formulation of ramucirumab, a drug approved for several types of cancer. In this study of healthy participants, a small amount of ramucirumab will be given by injection either into a vein or just under the skin. Study doctors will measure the amount of ramucirumab in the bloodstream. Side effects and tolerability will be documented. The study will last for about 16 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through Day 90

• Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug

  Number of participants showing ISRs when the drug was administered subcutaneously were reported.

  Day 1 Predose through Day 90

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab

  PK: AUC\[0-∞\] of Ramucirumab.

  1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose

• PK: Maximum Concentration (Cmax) of Ramucirumab

  PK: Cmax of Ramucirumab

  1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose

Study Arms (7)

Placebo - Intravenous (IV)

EXPERIMENTAL

Participants received single dose of placebo administered IV.

Drug: Placebo - IV

350 mg Ramucirumab IV

PLACEBO COMPARATOR

Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion.

Drug: Ramucirumab - IV

Placebo - Subcutaneous (SC)

EXPERIMENTAL

Participants received single dose of placebo administered SC.

Drug: Placebo - SC

350 mg Ramucirumab SC (1x2 mL)

PLACEBO COMPARATOR

Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.

Drug: Ramucirumab - SC

350 mg Ramucirumab SC (2x2 mL)

EXPERIMENTAL

Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.

Drug: Ramucirumab - SC

350 mg Ramucirumab SC (2x1 mL)

EXPERIMENTAL

Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.

Drug: Ramucirumab - SC

700 mg Ramucirumab SC (2x2 mL)

EXPERIMENTAL

Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.

Drug: Ramucirumab - SC

Interventions

Ramucirumab - IV DRUG

Administered IV.

Also known as: LY3009806

350 mg Ramucirumab IV

Placebo - IV DRUG

Administered IV.

Placebo - Intravenous (IV)

Ramucirumab - SC DRUG

Administered SC.

Also known as: LY3009806

350 mg Ramucirumab SC (1x2 mL); 350 mg Ramucirumab SC (2x1 mL); 350 mg Ramucirumab SC (2x2 mL); 700 mg Ramucirumab SC (2x2 mL)

Placebo - SC DRUG

Administered SC.

Placebo - Subcutaneous (SC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
• Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

You may not qualify if:

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

Ramucirumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: No
• Restriction Type: OTHER
• Restrictive Agreement: 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: July 30, 2020
• First Posted: July 31, 2020
• Study Start: July 30, 2020
• Primary Completion: May 9, 2021
• Study Completion: May 9, 2021
• Last Updated: February 14, 2023
• Results First Posted: February 14, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)