Healthy VolunteersEarly Phase 1NCT06194578
A Study of Sterile Saline Infusion in Healthy Volunteers
A Early Phase 1 study testing Sterile Saline in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sterile Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 23 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19148
About this study
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
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
- Being tested
- Sterile Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile SalineOther
Sterile saline will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 10 minutes after completion of the saline solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start12 Jan 2024
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194578
- Sponsor's protocol ID
- TV-TEC-275823
- Status last verified
- May 2025
- First submitted
- 22 Dec 2023
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Torjman MC, Spiegel S, Loeum C, Lessin J, Joseph JI. Safety and tolerability study of subcutaneous injections of larger volumes in abdominal and lower extremity sites suitable for autoinjectors. Expert Opin Drug Deliv. 2026 Oct 30:1-12. doi: 10.1080/17425247.2026.2748243. Online ahead of print.
PubMed 42954954
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06194578
- Acronym / sponsor ID
- TV-TEC-275823
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Infusion of Sterile Saline | Experimental | Other: Sterile SalineParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile SalineSterile saline will be administered subcutaneously. | Other | Subcutaneous Infusion of Sterile Saline |
Primary outcome
Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score
Time frame: Up to 10 minutes after completion of the saline infusion
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.
Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)
Time frame: Up to 10 minutes after completion of the saline solution
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 42954954Torjman MC, Spiegel S, Loeum C, Lessin J, Joseph JI. Safety and tolerability study of subcutaneous injections of larger volumes in abdominal and lower extremity sites suitable for autoinjectors. Expert Opin Drug Deliv. 2026 Oct 30:1-12. doi: 10.1080/17425247.2026.2748243. Online ahead of print.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sterile Saline in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score (time frame: Up to 10 minutes after completion of the saline infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.