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Comfort check: how do different injection methods for IgG stack up?

NCT ID NCT07025577

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Daytona Beach Clinical Rsch Unit

    Daytona Beach, Florida, 32117, United States

  • Fortrea Clinical Research Unit - Dallas

    Dallas, Texas, 75247-4989, United States

  • Fortrea Clinical Research Unit Inc. - Madison

    Madison, Wisconsin, 53704-2526, United States

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