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The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are:
Participants will
This is a single center, randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical study, aiming to evaluate the efficacy, safety, immunogenicity and pharmacokinetic of PN20 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PN20 group | Experimental | subcutaneous injections, a single dose |
|
| Placebo group | Placebo Comparator | subcutaneous injections, a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN20 | Drug | Six dose levels of PN20 will be evaluated |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Adverse Events | Number of participants with treatment-related adverse events during the study will be collected and the percentage of AE of different grades as assessed by CTCAE v5.0 will be assessed. | up to 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangshu | 215006 | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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It is an open-label study at first dose level, and switched to double-blind study starting from the second dose level.
| Placebo | Drug | Placebo of PN20 |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |