A Study of Sterile Saline Infusion in Healthy Volunteers

Early Phase 1CompletedNCT06194578

Janssen Research & Development, LLC32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Sterile SalineOTHER

Sterile saline will be administered subcutaneously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score

Participant's pain intensity during or after the saline infusion as assessed by VAS score will be reported. VAS is a self-reported pain rating scale ranging 0=no pain to 100=worst possible pain.

Time frame: Up to 10 minutes after completion of the saline infusion

Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)

Participant's pain intensity during or after the saline infusion as assessed by VPS will be reported. VPS will be graded by participants as none, mild, moderate, and severe.

Time frame: Up to 10 minutes after completion of the saline solution

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.