RabiesNCT07706907
An Expanded Access Program for SYN023 in Rabies Treatment
A study testing Zamerovimab and Mazorelvimab Injection in people with Rabies, run by Synermore Biologics (Suzhou) Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rabies
- What is being tested?
- Zamerovimab and Mazorelvimab Injection
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Must be ineligible for or lack access to other investigational or approved therapies
- Must have no available alternative curative treatment options
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sponsor-Initiated Expanded Access Program (SYN023-EAP-001) for SYN023 (Zamerovimab + Mazorelvimab): Compassionate Use of SYN023 in Patients With Confirmed or Suspected Life-Threatening Rabies Infection
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.
Read the 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.
- Conditions
- Rabies
- Being tested
- Zamerovimab and Mazorelvimab Injection
- Keywords
- Rabies, SYN023
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zamerovimab and Mazorelvimab InjectionDrug
Also called SYN023
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Synermore Biologics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706907
- Sponsor's protocol ID
- SYN023-EAP-001
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sponsor-Initiated Expanded Access Program (SYN023-EAP-001) for SYN023 (Zamerovimab + Mazorelvimab): Compassionate Use of SYN023 in Patients With Confirmed or Suspected Life-Threatening Rabies Infection
- ClinicalTrials.gov ID
- NCT07706907
- Acronym / sponsor ID
- SYN023-EAP-001
- Conditions
- Rabies
- Keywords
- Rabies, SYN023
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Synermore Biologics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be ineligible for or lack access to other investigational or approved therapies
- Must have no available alternative curative treatment options
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zamerovimab and Mazorelvimab InjectionAlso: SYN023SYN023 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Related trials for Rabies
Active, not recruitingPhase 3
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
Rabies
Active, not recruitingObservational study
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
Rabies Post-exposure Prophylaxis, Rabies
RecruitingObservational study
Real World Evidence Study of SYN023 in Children Exposed to Rabies
Rabies Post-exposure Prophylaxis
Enrolling by invitationPhase 3
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
Rabies Prevention
Not yet recruitingPhase 3
Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.
Rabies (Healthy Volunteers)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Zamerovimab and Mazorelvimab Injection in people with Rabies, run by Synermore Biologics (Suzhou) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Tsao (+86 18550278707, etsao@synermore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.