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Immunoglobulin G

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Sep 10, 2025

Immunoglobulin G development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 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

Immunoglobulin G clinical trials

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?

Immunoglobulin G is an investigational small molecule therapeutic being developed by Roche Holding AG. It is in Phase 1 clinical development, with one completed trial conducted in healthy participants. The specific disease indications for which it is being studied have not been disclosed.

Who is developing Immunoglobulin G?

Immunoglobulin G is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is responsible for advancing the asset through clinical development, and it has completed one Phase 1 trial of the therapy in healthy participants.

What phase is Immunoglobulin G in?

Immunoglobulin G is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.

What clinical trials is Immunoglobulin G in?

Immunoglobulin G has been evaluated in one completed Phase 1 trial, NCT07025577. The study assessed the tolerability and safety of subcutaneously administered Immunoglobulin G with varying injection conditions in 82 healthy participants in the United States. It was randomized and controlled but not double blind.

What is Immunoglobulin G used for?

Immunoglobulin G is being studied as an investigational therapy, but the specific indications have not been disclosed. Its completed Phase 1 trial enrolled healthy participants rather than patients with a defined disease, so no therapeutic indication has been publicly specified.