A Study of Sterile Saline Infusion in Healthy Volunteers

Early Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Sterile Saline

• Registration Number: NCT06194578
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Study First Posted: 2024-01-08
• Study Start: 2024-01-12
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subcutaneous Infusion of Sterile Saline	Sterile Saline	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.

Primary Outcome Measures

Name	Time	Method
Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)	Up to 10 minutes after completion of the saline solution	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.
Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score	Up to 10 minutes after completion of the saline infusion	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.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States