A Study of Sterile Saline Infusion in Healthy Volunteers

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Sterile Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06194578

TV-TEC-275823

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Subcutaneous Infusion of Sterile Saline

Experimental group

Description:

Participants will receive sterile saline subcutaneous infusion administered into abdomen and/or anterior thigh through various sizes of needles at various volume and rate of delivery at Visit 1.

Treatment:

Other: Sterile Saline