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This sponsor-initiated Expanded Access Program provides compassionate-use SYN023, a dual monoclonal antibody cocktail (zamerovimab + mazorelvimab) targeting rabies virus glycoprotein, for US patients with confirmed or suspected life-threatening rabies lacking adequate alternative therapies.
The goal of this expanded access program is to learn about the safety and clinical outcomes of SYN023 in patients with confirmed or suspected rabies infection who receive SYN023 as compassionate-use treatment for life-threatening rabies. The main question it aims to answer is:
Does SYN023 provide clinical benefit and demonstrate manageable safety profiles in patients with confirmed or suspected life-threatening rabies when administered alongside standard rabies care? Participants receiving SYN023 as part of their emergency compassionate-use care for rabies will have clinical safety, serologic and disease course data collected throughout their treatment course to support continuous pharmacovigilance and future SYN023 clinical development.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zamerovimab and Mazorelvimab Injection | Drug | SYN023 may be administered with rabies treatments according to the local standard of care; local standard of care may include the Milwaukee Protocol if the treating clinician and patient so choose. |
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Inclusion Criteria:
Exclusion Criteria:
No standardized universal exclusion criteria are predefined for this Expanded Access Program.
- Clinical contraindications identified on an individual basis by the treating critical care clinician
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Tsao | Contact | +86 18550278707 | etsao@synermore.com | |
| Xiangjun Li | Contact | +86 18898880617 | xjli@synermore.cn |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| D007239 | Infections |