HealthyPhase 1NCT04495478
A Study of Ramucirumab (LY3009806) in Healthy Participants
A Phase 1 study testing Ramucirumab - IV and Ramucirumab - SC in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ramucirumab - IV and Ramucirumab - SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to 9 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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- Have previously participated or withdrawn from this study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
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
About this study
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
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
- Being tested
- Ramucirumab - IV, Placebo - IV, Ramucirumab - SC, Placebo - SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramucirumab - IVDrug
Also called LY3009806
Administered IV.
Placebo - IVDrug
Administered IV.
Ramucirumab - SCDrug
Also called LY3009806
Administered SC.
Placebo - SCDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Placebo - Intravenous (IV) | Experimental | Participants received single dose of placebo administered IV. Receives: 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. Receives: Drug: Ramucirumab - IV |
| Placebo - Subcutaneous (SC) | Experimental | Participants received single dose of placebo administered SC. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Ramucirumab - SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start30 Jul 2020
- Primary completion9 May 2021
- Study completion9 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495478
- Sponsor's protocol ID
- 17748
- Other IDs
- I4T-MC-JVDT
- Status last verified
- May 2022
- First submitted
- 30 Jul 2020
- Last updated
- 14 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04495478
- Acronym / sponsor ID
- 17748
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 9 May 2021 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Posted 14 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo - Intravenous (IV) | Experimental | Drug: Placebo - IVParticipants received single dose of placebo administered IV. |
| 350 mg Ramucirumab IV | Placebo comparator | Drug: Ramucirumab - IVParticipants 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. |
| Placebo - Subcutaneous (SC) | Experimental | Drug: Placebo - SCParticipants received single dose of placebo administered SC. |
| 350 mg Ramucirumab SC (1x2 mL) | Placebo comparator | Drug: Ramucirumab - SCParticipants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. |
| 350 mg Ramucirumab SC (2x2 mL) | Experimental | Drug: Ramucirumab - SCParticipants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. |
| 350 mg Ramucirumab SC (2x1 mL) | Experimental | Drug: Ramucirumab - SCParticipants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. |
| 700 mg Ramucirumab SC (2x2 mL) | Experimental | Drug: Ramucirumab - SCParticipants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramucirumab - IVAlso: LY3009806Administered IV. | Drug | 350 mg Ramucirumab IV |
| Placebo - IVAdministered IV. | Drug | Placebo - Intravenous (IV) |
| Ramucirumab - SCAlso: LY3009806Administered SC. | Drug | 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 - SCAdministered SC. | Drug | Placebo - Subcutaneous (SC) |
Primary outcome
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
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
Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug
Time frame: Day 1 Predose through Day 90
Number of participants showing ISRs when the drug was administered subcutaneously were reported.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab
Time frame: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
PK: AUC[0-∞] of Ramucirumab.
PK: Maximum Concentration (Cmax) of Ramucirumab
Time frame: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose
PK: Cmax of Ramucirumab
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ramucirumab - IV and Ramucirumab - SC in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.