COMPLETED

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

Talk to us

Conditions

Healthy Participants

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-06-02
Study Completion:2025-09-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT07025577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) 18 to 36 kilograms per meter square (kg/m\^2), inclusive
  2. * 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
  3. * For males: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
  1. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the last study drug administration
  2. * Positive human immunodeficiency virus (HIV) test
  3. * Positive hepatitis B surface antigen or hepatitis B core antibody test
  4. * Positive hepatitis C virus antibody test
  5. * Regular alcohol consumption of \>8 drinks/week for females or \>12 drinks/week for males
  6. * Poor peripheral venous access
  7. * Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the study
  8. * Known hypersensitivity to IgG or any of its components or to products made with IgG
  9. * History or presence of skin rash or other skin disorders
  10. * Inability to sense pain (e.g., peripheral neuropathy) or have a history of or have been diagnosed with a chronic pain syndrome
  11. * Infection or inflammation of the designated injection site (abdomen)

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Genentech, Inc.

Study Locations (Sites)

Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, 32117
United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4989
United States
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-02
Study Completion Date2025-09-03

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2025-09-03

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Participants