Healthy ParticipantsPhase 1NCT07025577
A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
A Phase 1 study testing Immunoglobulin G in people with Healthy Participants, run by Genentech, Inc. at 3 sites in United States.
Trial summary
This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Immunoglobulin G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jun 2025to 3 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4989
Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, 32117
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
About this study
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
This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Immunoglobulin G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin GDrug
Participants will receive SC administrations of IgG
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A. Receives: Drug: Immunoglobulin G |
| Sequence 2 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C. Receives: Drug: Immunoglobulin G |
| Sequence 3 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C. Receives: Drug: Immunoglobulin G |
| Sequence 4 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D. Receives: Drug: Immunoglobulin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)
Measured: Up to Day 4
Mean Change From Baseline in Injection Site Tolerability Score on VAS
Measured: Baseline, Up to Day 4
Percentage of Participants Experiencing Greater Than Mild Pain
Measured: Up to Day 4
Percentage of Participants in Each VDS Category on the VDS Scale
Measured: Up to Day 4
Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)
Measured: Up to Day 7
Participant's Tolerability to Injection as Assessed by Tolerability Questionnaire
Measured: Up to Day 4
Number of Participants with Visual Injection Site Tolerability as assessed using LISSA
Measured: Up to Day 4
Number of Participants with Fluid Leakage
Measured: Up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start2 Jun 2025
- Primary completion8 Aug 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025577
- Sponsor's protocol ID
- GP45580
- Status last verified
- Sep 2025
- First submitted
- 30 May 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07025577
- Acronym / sponsor ID
- GP45580
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Immunoglobulin GParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A. |
| Sequence 2 | Experimental | Drug: Immunoglobulin GParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C. |
| Sequence 3 | Experimental | Drug: Immunoglobulin GParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C. |
| Sequence 4 | Experimental | Drug: Immunoglobulin GParticipants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoglobulin GParticipants will receive SC administrations of IgG | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)
Time frame: Up to Day 4
Mean Change From Baseline in Injection Site Tolerability Score on VAS
Time frame: Baseline, Up to Day 4
Percentage of Participants Experiencing Greater Than Mild Pain
Time frame: Up to Day 4
Percentage of Participants in Each VDS Category on the VDS Scale
Time frame: Up to Day 4
Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)
Time frame: Up to Day 7
Participant's Tolerability to Injection as Assessed by Tolerability Questionnaire
Time frame: Up to Day 4
Number of Participants with Visual Injection Site Tolerability as assessed using LISSA
Time frame: Up to Day 4
Number of Participants with Fluid Leakage
Time frame: Up to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immunoglobulin G in people with Healthy Participants, run by Genentech, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS) (time frame: Up to Day 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.