Comfort check: how do different injection methods for IgG stack up?
NCT ID NCT07025577
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested how well healthy adults tolerate immunoglobulin G (IgG) injections given under the skin using different techniques. Researchers measured pain, injection-site reactions, and fluid leakage in 82 participants. The goal was to find the most comfortable and safe way to deliver IgG, which is used to treat immune disorders.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Immunoglobulin G (IgG)
- What this could lead to
- If successful, this could help make future IgG injections more comfortable for patients who need regular doses.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. Results may not apply to real-world use, and side effects like injection-site pain or reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
82 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Body mass index (BMI) 18 to 36 kilograms per meter square (kg/m\^2), inclusive * For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during IgG administration and for 28 days after completion of IgG administration * For males: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the last study drug administration * Positive human immunodeficiency virus (HIV) test * Positive hepatitis B surface antigen or hepatitis B core antibody test * Positive hepatitis C virus antibody test * Regular alcohol consumption of \>8 drinks/week for females or \>12 drinks/week for males * Poor peripheral venous access * Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the study * Known hypersensitivity to IgG or any of its components or to products made with IgG * History or presence of skin rash or other skin disorders * Inability to sense pain (e.g., peripheral neuropathy) or have a history of or have been diagnosed with a chronic pain syndrome * Infection or inflammation of the designated injection site (abdomen)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, 32117, United States
-
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4989, United States
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Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526, United States
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