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A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
Healthy Volunteers
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Trial Identifier
NCT07025577, GP45580
Condition
Healthy Participants
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 Summary
This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.
Eligibility Criteria
All
≥18 Years & ≤ 65 Years
Accepts Healthy Volunteers
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)
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com