A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.
Key facts
- Study ID
- NCT07025577
- Run by
- Genentech, Inc.
- People needed
- 82
- Starts
- 2025-06-02
- Expected to finish
- 2025-09-03
- Last updated by the study team
- 2025-09-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Daytona Beach Clinical Rsch Unit — Daytona Beach, Florida, United States
- Fortrea Clinical Research Unit - Dallas — Dallas, Texas, United States
- Fortrea Clinical Research Unit Inc. - Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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