Rabies
Conditions
Keywords
Rabies, SYN023
Brief summary
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.
Detailed description
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.
Interventions
DRUGZamerovimab and Mazorelvimab Injection
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.
Sponsors
Synermore Biologics (Suzhou) Co., Ltd.
Eligibility
Sex/Gender
ALL
Inclusion criteria
* Must be ineligible for or lack access to other investigational or approved therapies * Must have no available alternative curative treatment options
Exclusion criteria
No standardized universal
Contacts
CONTACTEric Tsao
CONTACTXiangjun Li
Outcome results
None listed