Healthy Participants
Conditions
Brief summary
This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.
Interventions
DRUGImmunoglobulin G
Participants will receive SC administrations of IgG
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed