A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
NCT ID: NCT07025577
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
82 participants
INTERVENTIONAL
2025-06-02
2025-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Sequence 1
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A.
Immunoglobulin G
Participants will receive SC administrations of IgG
Sequence 2
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C.
Immunoglobulin G
Participants will receive SC administrations of IgG
Sequence 3
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C.
Immunoglobulin G
Participants will receive SC administrations of IgG
Sequence 4
Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D.
Immunoglobulin G
Participants will receive SC administrations of IgG
Interventions
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Immunoglobulin G
Participants will receive SC administrations of IgG
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Countries
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Other Identifiers
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GP45580
Identifier Type: -
Identifier Source: org_study_id
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