A Study of Sterile Saline Infusion in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2024-04-23

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subcutaneous Infusion of Sterile Saline

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.

Group Type EXPERIMENTAL

Sterile Saline

Intervention Type OTHER

Sterile saline will be administered subcutaneously.

Interventions

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Sterile Saline

Sterile saline will be administered subcutaneously.

Intervention Type OTHER

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes