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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20220973 | Registry Identifier | National Medical Products Administration of China |
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This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.
This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.
The sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).
Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYB1904/JYB1904 Placebo | Experimental | single-dose; subcutaneous injection in the deltoid region of the upper arm. |
|
| Omalizumab | Active Comparator | single-dose; subcutaneous injection in the deltoid region of the upper arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYB1904 | Drug | Dosage form: injection, solution; Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence and features of AEs assessed by CTCAE v5.0 | Baseline through 168 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of JYB1904 and Omalizumab | Serum JYB1904 and Omalizumab assessed by pre-specified methods, and related pharmacokinetic parameters analysis | Baseline through 168 days post-dose |
| Serum concentrations of total/free IgE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guiling Chen, MD | Shulan (Hangzhou) Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shulan (Hangzhou) Hospital | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .
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JYB1904/JYB1904 Placebo Arm: double-blind (participant and investigator); Omalizumab Arm: non-blind.
| Omalizumab | Drug | Dosage form: injection, powder, lyophilized, for solution; Usage and dosage matching:dose 1; single-dose; subcutaneous injection in the deltoid region of the upper arm. |
|
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| JYB1904 Placebo | Drug | Dosage form: injection, solution; Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm. |
|
Serum total/free IgE assessed by a pre-specified method, and related pharmacodynamic parameters analysis
| Baseline through 168 days post-dose |
| Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab) | Serum ADA and Nab assessed by pre-specified methods, and related immunogenic features analysis | Baseline through 168 days post-dose |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |