A Study of Ramucirumab (LY3009806) in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo - IV; Drug: Ramucirumab - SC; Drug: Ramucirumab - IV; Drug: Placebo - SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04495478

17748

I4T-MC-JVDT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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• Have previously participated or withdrawn from this study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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 7 patient groups, including a placebo group

Placebo - Intravenous (IV)

Experimental group

Description:

Participants received single dose of placebo administered IV.

Treatment:

Drug: Placebo - IV

350 mg Ramucirumab IV

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ramucirumab - IV

Placebo - Subcutaneous (SC)

Experimental group

Description:

Participants received single dose of placebo administered SC.

Treatment:

Drug: Placebo - SC

350 mg Ramucirumab SC (1x2 mL)

Placebo Comparator group

Description:

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

Treatment:

Drug: Ramucirumab - SC

350 mg Ramucirumab SC (2x2 mL)

Experimental group

Description:

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

Treatment:

Drug: Ramucirumab - SC

350 mg Ramucirumab SC (2x1 mL)

Experimental group

Description:

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

Treatment:

Drug: Ramucirumab - SC

700 mg Ramucirumab SC (2x2 mL)

Experimental group

Description:

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

Treatment:

Drug: Ramucirumab - SC