A Study of Sterile Saline Infusion in Healthy Volunteers

NCT06194578 | Completed Early Phase 1 FDA Drug

• 1 other identifier: TV-TEC-275823
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Subcutaneous Infusion of Sterile Saline

EXPERIMENTAL

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.

Other: Sterile Saline

Interventions

Sterile Saline OTHER

Sterile saline will be administered subcutaneously.

Subcutaneous Infusion of Sterile Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19148, United States

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: January 12, 2024
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)