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Completed

NCT Number: NCT06194578

A Study of Sterile Saline Infusion in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sterile saline

Other

Sterile saline will be administered subcutaneously.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2024
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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