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Immunoglobulin G

Phase 1

Healthy Participants | Small molecule | Other |Roche Holding AG|Last Updated: Sep 10, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

Immunoglobulin G · 1 trial · 1 indication

Phase 1 1
NCT07025577A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection ConditionsHealthy Participants
COMPLETED82 Analytics
PHASE1COMPLETED
A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A.
Sequence 2EXPERIMENTALParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C.
Sequence 3EXPERIMENTALParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C.
Sequence 4EXPERIMENTALParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D.

Interventions

NameTypeDescription
Immunoglobulin GDRUGParticipants will receive SC administrations of IgG
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 completio...

Countries:United States
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Frequently asked questions about Immunoglobulin G

What is Immunoglobulin G used for?

Immunoglobulin G is being studied for use in healthy participants. It is an investigational small molecule being developed by Roche Holding AG. The drug is currently in Phase 1 clinical development, meaning it has not been approved for any use and is still being tested for safety and tolerability.

What does Immunoglobulin G target?

Immunoglobulin G does not have a specific molecular target or target class identified in its development program. It is being studied as a small molecule in healthy participants to assess its tolerability and safety when administered subcutaneously under varying injection conditions.

Who makes Immunoglobulin G?

Immunoglobulin G is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants.

What phase is Immunoglobulin G in?

Immunoglobulin G is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is Immunoglobulin G in?

Immunoglobulin G has one completed Phase 1 clinical trial, identified as NCT07025577. This study assessed the tolerability and safety of subcutaneously administered Immunoglobulin G with varying injection conditions in 82 healthy participants in the United States.

Is Immunoglobulin G the same as IgG?

Immunoglobulin G is commonly referred to as IgG. In clinical trials, the drug is studied under the name Immunoglobulin G (IgG), and the completed Phase 1 trial NCT07025577 evaluated its subcutaneous administration in healthy participants.