A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions

Launched by GENENTECH, INC. · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and how well people tolerate a medicine called immunoglobulin G (IgG) when it is given as an injection just under the skin. The study will be done in healthy adults to see if the different ways of giving this injection cause any problems or discomfort.

People who might take part are adults with a body weight in a healthy range (based on BMI between 18 and 36). Women who could become pregnant need to agree to avoid pregnancy during the study and for a short time afterward, and men also need to use protection or abstain from sex, as well as avoid donating sperm during the study. Participants should not be pregnant, have certain infections like HIV or hepatitis, or have conditions like skin problems or recent major surgery. During the study, participants will receive injections under the skin and be monitored to make sure the medicine is safe and well tolerated. This study is not yet recruiting, but it aims to help understand the best and safest way to give IgG injections.

Gender

ALL

Eligibility criteria

• 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)