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

Description

This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.

Conditions

Healthy Participants
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Healthy Participants

Study Overview

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Study Details

Study overview

This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.

A Phase 1, Open-Label, Fixed-Sequence, Randomized Study to Assess the Tolerability and Safety of Subcutaneously Administered Immunoglobulin G With Varying Injection Conditions

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

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Daytona Beach

Daytona Beach Clinical Rsch Unit, Daytona Beach, Florida, United States, 32117

Dallas

Fortrea Clinical Research Unit - Dallas, Dallas, Texas, United States, 75247-4989

Madison

Fortrea Clinical Research Unit Inc. - Madison, Madison, Wisconsin, United States, 53704-2526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

2025-09-03