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This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A. |
|
| Sequence 2 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C. |
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| Sequence 3 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C. |
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| Sequence 4 | Experimental | Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin G | Drug | Participants will receive SC administrations of IgG |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach Clinical Rsch Unit | Daytona Beach | Florida | 32117 | United States | ||
| Fortrea Clinical Research Unit - Dallas |
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| Dallas |
| Texas |
| 75247-4989 |
| United States |
| Fortrea Clinical Research Unit Inc. - Madison | Madison | Wisconsin | 53704-2526 | United States |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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