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

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: Immunoglobulin G

• Registration Number: NCT07025577
• Lead Sponsor: Genentech, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-30
• Status Verified: 2025-06
• Study Start: 2025-06-02
• Study First Submitted QC: 2025-06-13
• Study First Posted: 2025-06-17
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-08-11
• Study Completion: 2025-09-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequence 1	Immunoglobulin G	Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A.
Sequence 2	Immunoglobulin G	Participants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C.
Sequence 3	Immunoglobulin G	Participants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C.
Sequence 4	Immunoglobulin G	Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D.

Primary Outcome Measures

Name	Time	Method
Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)	Up to Day 4
Mean Change From Baseline in Injection Site Tolerability Score on VAS	Baseline, Up to Day 4
Percentage of Participants Experiencing Greater Than Mild Pain	Up to Day 4
Percentage of Participants in Each VDS Category on the VDS Scale	Up to Day 4
Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)	Up to Day 7
Participant's Tolerability to Injection as Assessed by Tolerability Questionnaire	Up to Day 4
Number of Participants with Visual Injection Site Tolerability as assessed using LISSA	Up to Day 4
Number of Participants with Fluid Leakage	Up to Day 4

Trial Locations

Locations (3)

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