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Nerve Growth Factor(NGF)plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the blockade of NGF signal pathway.
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) administered EP-9001A in healthy Chinese subjects.
Nerve Growth Factor(NGF)plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the blockade of NGF signal pathway.
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) administered EP-9001A in healthy Chinese subjects.
The initial dose of the study was set as 1 mg, and the doses were escalated sequentially in the order of 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 25 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP-9001A | Experimental | Dose-escalation trial |
|
| Placebo | Placebo Comparator | Dose-escalation trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP-9001A | Drug | The initial dose of the study was set as 1 mg, and the doses were escalated sequentially in the order of 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of Adverse Events,MTD | All adverse events occurring throughout the study were assessed and graded. the maximum tolerated dose (MTD) | Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics of EP-9001A | EP-9001A serum concentrations over time | Baseline to week 8 |
| immunogenicity assessed by ADA | Presence of anti-drug antibodies over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ping feng, MD | Contact | +86 153 8821 6625 | 617130961@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | China |
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|
| placebo | Drug | placebo |
|
| Baseline to week 8 |