A Study of Sterile Saline Infusion in Healthy Volunteers

A Phase 0, Single-Center Study to Evaluate the Safety and Tolerability of Injecting Sterile Saline Subcutaneously Into the Abdomen and Thigh of Healthy Volunteers Using Varying Volumes and Rates of Infusion

The purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.

Inclusion Criteria:

• Body Mass Index greater than (>)18 and less than (<) 36
• Able to understand the English language
• Has a negative coronavirus-2019 (COVID-19) test result at the time of admission, prior to administration of study intervention

Exclusion Criteria:

• Age < 18 years and > 60 years
• BMI < 18 or > 36
• Unable to understand the English language
• Currently pregnant or lactating
• History of skin sensitivity or allergy to steel needle or adhesive tape
• History of abnormal blood coagulation or bleeding
• History of abnormal immune function or frequent skin infections
• Active cardiovascular, pulmonary, dermatologic, endocrine, rheumatologic, hematologic, ophthalmologic, psychiatric, metabolic, hepatic, renal, immune, gastrointestinal, neurological, or musculoskeletal disease
• Has tattoo(s) or scarring at the site of injection or any other condition which may interfere with the injection site examination, in the opinion of the investigator