Clinical trial NCT07025577: A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
Official title: A Phase 1, Open-Label, Fixed-Sequence, Randomized Study to Assess the Tolerability and Safety of Subcutaneously Administered Immunoglobulin G With Varying Injection Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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)

Primary outcomes:
measure: Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)
timeFrame: Up to Day 4
measure: Mean Change From Baseline in Injection Site Tolerability Score on VAS
timeFrame: Baseline, Up to Day 4
measure: Percentage of Participants Experiencing Greater Than Mild Pain
timeFrame: Up to Day 4
measure: Percentage of Participants in Each VDS Category on the VDS Scale
timeFrame: Up to Day 4
measure: Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)
timeFrame: Up to Day 7
measure: Participant's Tolerability to Injection as Assessed by Tolerability Questionnaire
timeFrame: Up to Day 4
measure: Number of Participants with Visual Injection Site Tolerability as assessed using LISSA
timeFrame: Up to Day 4
measure: Number of Participants with Fluid Leakage
timeFrame: Up to Day 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: