A Study of Sterile Saline Infusion in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06194578
• Other study ID #: TV-TEC-275823
• Status: Completed
• Phase: Early Phase 1
• Start date: January 12, 2024
• Est. completion date: April 23, 2024

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Infertility

Intervention

Other:
• Sterile Saline
Sterile saline will be administered subcutaneously.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10 minutes after completion of the saline infusion
Primary	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.	Up to 10 minutes after completion of the saline solution