Status:
COMPLETED
A Study of Sterile Saline Infusion in Healthy Volunteers
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06194578
Start Date
January 12 2024
End Date
April 23 2024
Last Update
May 23 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19148