A Study of Ramucirumab (LY3009806) in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT04495478|
Recruitment Status : Active, not recruiting
First Posted : July 31, 2020
Last Update Posted : February 21, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Ramucirumab - IV Drug: Placebo - IV Drug: Ramucirumab - SC Drug: Placebo - SC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Single-Dose Study in Healthy Participants to Characterize Ramucirumab Pharmacokinetics and Investigate Injection Site Reactions Following an Intravenous Infusion or Subcutaneous Administration of Ramucirumab|
|Actual Study Start Date :||July 30, 2020|
|Estimated Primary Completion Date :||May 9, 2021|
|Estimated Study Completion Date :||May 9, 2021|
Experimental: Ramucirumab - Intravenous (IV)
Ramucirumab administered IV.
Drug: Ramucirumab - IV
Other Name: LY3009806
Placebo Comparator: Placebo - IV
Placebo administered IV.
Drug: Placebo - IV
Experimental: Ramucirumab - Subcutaneous (SC)
Ramucirumab administered SC.
Drug: Ramucirumab - SC
Other Name: LY3009806
Placebo Comparator: Placebo - SC
Placebo administered SC.
Drug: Placebo - SC
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Day 90 ]A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Percentage of Participants with an Injection Site Reaction (ISR[s]) [ Time Frame: Day 1 Predose through Day 90 ]Percentage of Participants with an ISR(s)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Ramucirumab [ Time Frame: Baseline through Day 90 ]PK: AUC of Ramucirumab
- PK: Maximum Concentration (Cmax) of Ramucirumab [ Time Frame: Baseline through Day 90 ]PK: Cmax of Ramucirumab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495478
|United States, Florida|
|Covance Clinical Research Inc|
|Daytona Beach, Florida, United States, 32117|
|Study Director:||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|