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Completed

NCT Number: NCT07025577

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

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

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Key information

Conditions

Healthy Participants

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach Clinical Rsch Unit, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immunoglobulin G

Drug

Participants will receive SC administrations of IgG

Primary outcomes

  1. Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)

    Time frame: Up to Day 4

  2. Mean Change From Baseline in Injection Site Tolerability Score on VAS

    Time frame: Baseline, Up to Day 4

  3. Percentage of Participants Experiencing Greater Than Mild Pain

    Time frame: Up to Day 4

  4. Percentage of Participants in Each VDS Category on the VDS Scale

    Time frame: Up to Day 4

  5. Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)

    Time frame: Up to Day 7

  6. Participant's Tolerability to Injection as Assessed by Tolerability Questionnaire

    Time frame: Up to Day 4

  7. Number of Participants with Visual Injection Site Tolerability as assessed using LISSA

    Time frame: Up to Day 4

  8. Number of Participants with Fluid Leakage

    Time frame: Up to Day 4

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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