<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04495569</url>
  </required_header>
  <id_info>
    <org_study_id>SYN023-005</org_study_id>
    <nct_id>NCT04495569</nct_id>
  </id_info>
  <brief_title>A Bridging Study of the SYN023 on Healthy Adult Subjects</brief_title>
  <official_title>A Phase 1 Single Center, Parallel, Open Label Bridging Study to Evaluate on the Safety, Pharmacokinetic, Pharmacodynamics and Anti-drug Antibodies (ADA) of a Single Intramuscular Doses of SYN023 in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Synermore Biologics (Suzhou) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Synermore Biologics (Suzhou) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Phase I bridging clinical trial is to evaluate on the safety, pharmacokinetics (PK),&#xD;
      pharmacodynamics (PD) and ADA of a single intramuscular injection of recombinant anti-rabies&#xD;
      human monoclonal antibody injection (SYN023) alone or combined with rabies vaccine in healthy&#xD;
      subjects. The study primary purpose was to compare the pharmacokinetics (PK) between U.S and&#xD;
      China subjects, therefore to lay a foundation for the follow-up clinical trials. The&#xD;
      secondary purpose was to evaluate the PK, PD, Safety and ADA of SYN023 in Chinese Healthy&#xD;
      subjects and compare with that of U.S. subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this bridging study. the Pharmacodynamic, Pharmacokinetic, Safety and ADA(Anti-Drug&#xD;
      Antibodies) were evaluated and compared between U.S. and China subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Cohort A: Intramuscular 0.3 mg/kg SYN023 Cohort B: Intramuscular 0.3 mg/kg SYN023 + China licensed Vero Cell Rabies Vaccine (PEP)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the Tmax between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine</measure>
    <time_frame>85 days</time_frame>
    <description>Interval from time 0 to maximum measured concentration of CTB011 and CTB012 (SYN023 components) at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To compare the Cmax between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.</measure>
    <time_frame>85 days</time_frame>
    <description>maximum concentration of CTB011 and CTB012 (SYN023 components) at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To compare the t1/2 between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.</measure>
    <time_frame>85 days</time_frame>
    <description>The half life of CTB011 and CTB012 (SYN023 components) were estimated at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To compare the Clearance rate between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.</measure>
    <time_frame>85 days</time_frame>
    <description>The clearance rate of CTB011 and CTB012 (SYN023 components) were estimated at at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012</measure>
    <time_frame>85 days</time_frame>
    <description>The area under the time concentration curve for SYN023 mAb components CTB011 and CTB012 were estimated at at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Event Incidence of healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine</measure>
    <time_frame>85 days</time_frame>
    <description>Electrocardiograms are performed to monitor subject safety. Laboratory evaluations for subject safety (adverse events) are serum chemistry evaluations, blood urea nitrogen, creatinine, bilirubin, alanine amino transferase, aspartate amino transferase, creatine phosphokinase, troponin, potassium, sodium, bicarbonate, calcium, complete blood count, platelet count, differential count, PT(prothrombin time, international normalized ratio) and PTT (partial prothrombin time and urinalyses for monitoring of safety. Additional laboratory tests may be required for evaluation of specific adverse events such as anaphylaxis and immune complex diseases. Adverse events were analyzed. A comparison of adverse event incidence between a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine were performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the antibody protection level RVNA (Rabies Virus Neutralizing Antibodies)≥ 0.5 IU/mL of serum from healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine</measure>
    <time_frame>85 days</time_frame>
    <description>parallel the Cohort A and Cohort B to compare the antibody protection level (RVNA ≥ 0.5 IU/mL) between China and U.S. subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the RVNA (Rabies Virus Neutralizing Antibodies) of serum from healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine</measure>
    <time_frame>85 days</time_frame>
    <description>parallel the Cohort A and Cohort B to compare the RVNA between China and U.S. subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the ADA (Anti-Drug Antibodies) of serum from healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine</measure>
    <time_frame>85 days</time_frame>
    <description>parallel the Cohort A and Cohort B to compare the ADA between China and U.S. subjects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Communicable Disease Transmission</condition>
  <condition>Zoonotic Disease</condition>
  <condition>Rabies Human</condition>
  <condition>Vaccine Reaction</condition>
  <condition>Immunisation Reaction</condition>
  <arm_group>
    <arm_group_label>Group/Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single intramuscular injection of SYN023 at 0.3mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group/Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single intramuscular injection of SYN023 at 0.3mg/kg combined with the Chinese licensed Vero Cell Rabies Vaccine (following the PEP (Post-exposure Prophylaxis) recommendation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>recombinant anti-rabies human monoclonal antibody injection (SYN023)</intervention_name>
    <description>The finished product of SYN023 is a mixture of two anti-rabies human monoclonal antibodies, CTB011 and CTB012 by equal quantity, containing 3.0 mg/mL active ingredients in both.</description>
    <arm_group_label>Group/Cohort A</arm_group_label>
    <arm_group_label>Group/Cohort B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rabies Vaccine</intervention_name>
    <description>The Chinese licensed Vero Cell Freeze-dried Rabies Vaccine was injected to Cohort B as per the vaccination precedure on Days 1, 4, 8, 15, 28 respectively.</description>
    <arm_group_label>Group/Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign the informed consent before the trial, fully understand the trial contents,&#xD;
             process and possible adverse reactions, and cooperate to observe the adverse events;&#xD;
&#xD;
          2. Could participate the entire study according to the protocol;&#xD;
&#xD;
          3. Subjects including partners are willing to voluntarily take effective contraceptive&#xD;
             measures from screening to 6 months after the last study drug administration.&#xD;
&#xD;
          4. Male and female healthy subjects aged 18-50 (including 18 and 50 years old)&#xD;
&#xD;
          5. The weight of male subjects shall not be less than 50 kg, and that of female subjects&#xD;
             shall not be less than 45 kg and shall not be more than 90 kg. Body mass index (BMI) =&#xD;
             body weight (kg) / height^2 (m^2), body mass index should be in the range of 18-30&#xD;
             kg/m2 (including);&#xD;
&#xD;
          6. Physical examination and vital signs are in normal range or the abnormality without&#xD;
             clinical significance, and the body temperature is ≤ 37.6 °C.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smoked over 5 cigarettes per day for 3 months before the trial;&#xD;
&#xD;
          2. History of allergy (multi drugs and food allergy); history of severe allergic disease&#xD;
             or allergic reaction; including allergy to any component of this drug;&#xD;
&#xD;
          3. History of alcohol addiction (14 units of alcohol per week: 1 unit = 285 mL beer, or&#xD;
             25 mL spirits, or 100 mL wine);&#xD;
&#xD;
          4. Blood donation or massive blood loss (&gt; 450 mL) occurred within 3 months before&#xD;
             screening;&#xD;
&#xD;
          5. History of autoimmune diseases;&#xD;
&#xD;
          6. History of chronic hepatitis ;&#xD;
&#xD;
          7. History of rabies virus infection;&#xD;
&#xD;
          8. Other acute or chronic diseases (within 6 months) that may interfere with the safety&#xD;
             and efficacy evaluation of the subjects according to the investigator's judgment;&#xD;
&#xD;
          9. Receipt of an immunoglobulin or blood product within 90 days prior to study;&#xD;
&#xD;
         10. History of rabies vaccination;&#xD;
&#xD;
         11. Receipt of immunosuppressive medications included the inhaled or local&#xD;
             immunosuppressant drugs within 45 days prior to Study;&#xD;
&#xD;
         12. Taken any prescribed, over-the-counter, vitamin product or herbal medicine within 14&#xD;
             days before screening;&#xD;
&#xD;
         13. Receipt of special diets (such as grapefruit) or endure strenuous physical exercise or&#xD;
             any other factors affecting drug absorption, distribution, metabolism and excretion&#xD;
             within 2 weeks before screening;&#xD;
&#xD;
         14. Had significant changes in diet or exercise habits recently;&#xD;
&#xD;
         15. Had been administrated with the investigational drug or participated in the clinical&#xD;
             trial of the drug within three months before taking the investigational drug;&#xD;
&#xD;
         16. The evidence of clinically significant of the abnormalities of 12 lead ECG ;&#xD;
&#xD;
         17. Female subjects in lactation or positive for serum pregnancy test during screening for&#xD;
             study;&#xD;
&#xD;
         18. Clinical significance of clinical laboratory results of screening, or suffered from&#xD;
             the following diseases, including but not limited to gastrointestinal tract, kidney,&#xD;
             liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio cerebrovascular&#xD;
             diseases within 6 months;&#xD;
&#xD;
         19. Positive in the screening of viral hepatitis (including hepatitis B and C), AIDS&#xD;
             antibody, and treponema pallidum antibody;&#xD;
&#xD;
         20. Acute disease or drug administration from the screening to the initial of the study;&#xD;
&#xD;
         21. History of taken chocolate, or any food or drink containing caffeine or rich xanthine&#xD;
             24 hours prior to administration of the study drug;&#xD;
&#xD;
         22. History of taken any alcoholic product within 24 hours prior to administration of the&#xD;
             study drug;&#xD;
&#xD;
         23. Drug abuse ;&#xD;
&#xD;
         24. Not suitable for enrolling in the study according to the investigator's judgment.&#xD;
&#xD;
             Additional exclusion criteria for Group B:&#xD;
&#xD;
         25. Clinical significance of Immunoglobulin A abnormalities according to the&#xD;
             investigator's judgment;&#xD;
&#xD;
         26. Undergoing anti-tuberculosis prophylaxis or treatment;&#xD;
&#xD;
         27. History of thyroidectomy, or treatment due to thyroid diseases in the past 12 months;&#xD;
&#xD;
         28. Diagnosed with serious angioneurotic edema in past 3 years or with the treatment in&#xD;
             the past two years prior to the study;&#xD;
&#xD;
         29. Advanced tumors, or neoplasm in treatment and shows no evidence of recovery, or may&#xD;
             relapse during the study;&#xD;
&#xD;
         30. No spleen or history of splenectomy;&#xD;
&#xD;
         31. Guillain-Barre syndrome or other serious neuropathy;&#xD;
&#xD;
         32. Receipt of live-attenuated vaccine within 30 days prior to the study;&#xD;
&#xD;
         33. Receipt of subunit or inactivated vaccine (such as pneumococcal vaccine), or allergy&#xD;
             treatment within 14 days prior to the study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jilin University</name>
      <address>
        <city>Changchun City</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Chao TY, Zhang SF, Chen L, Tsao E, Rupprecht CE. In Vivo Efficacy of SYN023, an Anti-Rabies Monoclonal Antibody Cocktail, in Post-Exposure Prophylaxis Animal Models. Trop Med Infect Dis. 2020 Feb 21;5(1):31. doi: 10.3390/tropicalmed5010031.</citation>
    <PMID>32098049</PMID>
  </reference>
  <results_reference>
    <citation>Chao TY, Ren S, Shen E, Moore S, Zhang SF, Chen L, Rupprecht CE, Tsao E. SYN023, a novel humanized monoclonal antibody cocktail, for post-exposure prophylaxis of rabies. PLoS Negl Trop Dis. 2017 Dec 20;11(12):e0006133. doi: 10.1371/journal.pntd.0006133. eCollection 2017 Dec.</citation>
    <PMID>29261658</PMID>
  </results_reference>
  <results_reference>
    <citation>Ding Y, Wu M, Zhang H, Zhu X, Hu Y, Li X, Liu J, Tsao E, Liu M, Li C. Safety, pharmacokinetics and pharmacodynamics of SYN023 alone or in combination with a rabies vaccine: An open, parallel, single dose, phase 1 bridging study in healthy Chinese subjects. Antiviral Res. 2020 Dec;184:104956. doi: 10.1016/j.antiviral.2020.104956. Epub 2020 Oct 19.</citation>
    <PMID>33091433</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bridging study</keyword>
  <keyword>Rabies Vaccine</keyword>
  <keyword>Monoclonal Antibody Cocktail</keyword>
  <keyword>Biologics,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabies</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Zoonoses</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495569
org study id: SYN023-005
nct id: NCT04495569
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The Phase I bridging clinical trial is to evaluate on the safety, pharmacokinetics (PK),
      pharmacodynamics (PD) and ADA of a single intramuscular injection of recombinant anti-rabies
      human monoclonal antibody injection (SYN023) alone or combined with rabies vaccine in healthy
      subjects. The study primary purpose was to compare the pharmacokinetics (PK) between U.S and
      China subjects, therefore to lay a foundation for the follow-up clinical trials. The
      secondary purpose was to evaluate the PK, PD, Safety and ADA of SYN023 in Chinese Healthy
      subjects and compare with that of U.S. subjects.
In this bridging study. the Pharmacodynamic, Pharmacokinetic, Safety and ADA(Anti-Drug
      Antibodies) were evaluated and compared between U.S. and China subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Cohort A: Intramuscular 0.3 mg/kg SYN023 Cohort B: Intramuscular 0.3 mg/kg SYN023 + China licensed Vero Cell Rabies Vaccine (PEP)
primary purpose: Treatment
masking: None (Open Label)
measure: To compare the Tmax between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine
time frame: 85 days
description: Interval from time 0 to maximum measured concentration of CTB011 and CTB012 (SYN023 components) at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.
measure: To compare the Cmax between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.
time frame: 85 days
description: maximum concentration of CTB011 and CTB012 (SYN023 components) at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.
measure: To compare the t1/2 between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.
time frame: 85 days
description: The half life of CTB011 and CTB012 (SYN023 components) were estimated at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.
measure: To compare the Clearance rate between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.
time frame: 85 days
description: The clearance rate of CTB011 and CTB012 (SYN023 components) were estimated at at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis.
measure: SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012
time frame: 85 days
description: The area under the time concentration curve for SYN023 mAb components CTB011 and CTB012 were estimated at at Day1-0 h (pre-dose), Day1-6 h, Day2(24 h), Day3(48 h), Day4(72 h), Day6(120 h), Day8(168 h), Day15(336 h), Day29(672 h), Day36(840 h), Day43(1008 h), Day64(1512 h), Day85(2016 h) post-dose, using non compartmental analysis
measure: Percentage of Participants With Adverse Event Incidence of healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine
time frame: 85 days
description: Electrocardiograms are performed to monitor subject safety. Laboratory evaluations for subject safety (adverse events) are serum chemistry evaluations, blood urea nitrogen, creatinine, bilirubin, alanine amino transferase, aspartate amino transferase, creatine phosphokinase, troponin, potassium, sodium, bicarbonate, calcium, complete blood count, platelet count, differential count, PT(prothrombin time, international normalized ratio) and PTT (partial prothrombin time and urinalyses for monitoring of safety. Additional laboratory tests may be required for evaluation of specific adverse events such as anaphylaxis and immune complex diseases. Adverse events were analyzed. A comparison of adverse event incidence between a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine were performed.
measure: To evaluate the antibody protection level RVNA (Rabies Virus Neutralizing Antibodies)≥ 0.5 IU/mL of serum from healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine
time frame: 85 days
description: parallel the Cohort A and Cohort B to compare the antibody protection level (RVNA ≥ 0.5 IU/mL) between China and U.S. subjects
measure: To evaluate the RVNA (Rabies Virus Neutralizing Antibodies) of serum from healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine
time frame: 85 days
description: parallel the Cohort A and Cohort B to compare the RVNA between China and U.S. subjects
measure: To evaluate the ADA (Anti-Drug Antibodies) of serum from healthy adult recipients of a single-dosed SYN023 0.3 mg/kg alone or combined with Rabies Vaccine
time frame: 85 days
description: parallel the Cohort A and Cohort B to compare the ADA between China and U.S. subjects
arm group label: Group/Cohort A
arm group type: Experimental
description: A single intramuscular injection of SYN023 at 0.3mg/kg
arm group label: Group/Cohort B
arm group type: Experimental
description: A single intramuscular injection of SYN023 at 0.3mg/kg combined with the Chinese licensed Vero Cell Rabies Vaccine (following the PEP (Post-exposure Prophylaxis) recommendation)
intervention type: Biological
intervention name: recombinant anti-rabies human monoclonal antibody injection (SYN023)
description: The finished product of SYN023 is a mixture of two anti-rabies human monoclonal antibodies, CTB011 and CTB012 by equal quantity, containing 3.0 mg/mL active ingredients in both.
arm group label: Group/Cohort A
arm group label: Group/Cohort B
intervention type: Biological
intervention name: Rabies Vaccine
description: The Chinese licensed Vero Cell Freeze-dried Rabies Vaccine was injected to Cohort B as per the vaccination precedure on Days 1, 4, 8, 15, 28 respectively.
arm group label: Group/Cohort B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
citation: Chao TY, Zhang SF, Chen L, Tsao E, Rupprecht CE. In Vivo Efficacy of SYN023, an Anti-Rabies Monoclonal Antibody Cocktail, in Post-Exposure Prophylaxis Animal Models. Trop Med Infect Dis. 2020 Feb 21;5(1):31. doi: 10.3390/tropicalmed5010031.
PMID: 32098049
citation: Chao TY, Ren S, Shen E, Moore S, Zhang SF, Chen L, Rupprecht CE, Tsao E. SYN023, a novel humanized monoclonal antibody cocktail, for post-exposure prophylaxis of rabies. PLoS Negl Trop Dis. 2017 Dec 20;11(12):e0006133. doi: 10.1371/journal.pntd.0006133. eCollection 2017 Dec.
PMID: 29261658
citation: Ding Y, Wu M, Zhang H, Zhu X, Hu Y, Li X, Liu J, Tsao E, Liu M, Li C. Safety, pharmacokinetics and pharmacodynamics of SYN023 alone or in combination with a rabies vaccine: An open, parallel, single dose, phase 1 bridging study in healthy Chinese subjects. Antiviral Res. 2020 Dec;184:104956. doi: 10.1016/j.antiviral.2020.104956. Epub 2020 Oct 19.
PMID: 33091433
responsible party type: Sponsor
mesh term: Rabies
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Zoonoses
mesh term: Antibodies
mesh term: Antibodies, Monoclonal
sharing ipd: No