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This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. A total of 294 healthy male adult participants, with 98 participants per treatment group across 3 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS101 injection | Experimental |
| |
| U.S. commercial dupilumab (Dupixent®) | Active Comparator |
| |
| China commercial dupilumab (Dupixent®) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS101 injection | Drug | 300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Endpoint | Cmax | 0-10 weeks |
| Pharmacokinetics Endpoint | AUC0-∞ | 0-10 weeks |
| Pharmacokinetics Endpoint | AUC0-t | 0-10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sinian Li, Master | Contact | +086-15800767550 | lisinian@jxingbio.com | |
| Tao Sun, Master | Contact | +086-15921575347 | suntao@jxingbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215004 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C540750 | GS 101 |
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| U.S. commercial Dupixent® | Drug | 300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions |
|
| CN commercial Dupixent® | Drug | 300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |