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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2024 |
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Main ID: |
NCT06194578 |
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Date of registration:
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22/12/2023 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Sterile Saline Infusion in Healthy Volunteers
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Scientific title:
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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 |
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Date of first enrolment:
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January 12, 2024 |
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Target sample size:
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32 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06194578 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Janssen Research & Development, LLC Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Research & Development, LLC |
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Name:
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Study Contact |
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Address:
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Telephone:
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844-434-4210 |
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Email:
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Participate-In-This-Study@its.jnj.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Other: Sterile Saline
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Primary Outcome(s)
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Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)
[Time Frame: Up to 10 minutes after completion of the saline solution]
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Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score
[Time Frame: Up to 10 minutes after completion of the saline infusion]
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Secondary ID(s)
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TV-TEC-275823
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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