A Study of Ramucirumab (LY3009806) in Healthy Participants

NCT04495478 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-02-14

Study results available
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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

Interventions

DRUG

Ramucirumab - IV

Administered IV.

DRUG

Placebo - IV

Administered IV.

DRUG

Ramucirumab - SC

Administered SC.

DRUG

Placebo - SC

Administered SC.

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2021-05-09
Completion
2021-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495478 on ClinicalTrials.gov