<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/NCT04468997</url>
  </required_header>
  <id_info>
    <org_study_id>3SGJ601-AMD</org_study_id>
    <nct_id>NCT04468997</nct_id>
  </id_info>
  <brief_title>The Study of Drug 601 in Patients With Wet Age-related Macular Degeneration (wAMD)</brief_title>
  <official_title>Phase I Clinical Trial of Recombinant Anti-VEGF Human Monoclonal Antibody in the Treatment of Wet Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter study to evaluate the safety and tolerability in patients with wet Age-related&#xD;
      macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF&#xD;
      monoclonal antibody&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the results of preclinical pharmacological research and clinical application of&#xD;
      bevacizumab in ophthalmology Case, 601 will be developed as a drug candidate for the&#xD;
      treatment of ocular diseases such as wAMD .Observe the safety and tolerability of the single&#xD;
      and multiple doses of 601 in wAMD patients; study the pharmacokinetic characteristics of&#xD;
      single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections&#xD;
      with different doses in the treatment of patients with wAMD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Anticipated">September 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DLT</measure>
    <time_frame>From Day 0 up to Day 14</time_frame>
    <description>Incidence of dose-limiting toxicities up to the Day 14 visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MTD</measure>
    <time_frame>From Day 0 up to Day 56/112.</time_frame>
    <description>Maximum tolerated dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) profile</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>Study the change of 601 drug concentration in the blood with time by mathematical principles and methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>The maximum blood concentration after 601 drug enters the bloodstream</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>The half-life of drug 601, the time required for the terminal phase 601 drug concentration to drop by half</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>Area under the concentration-time curve, reflect the characteristics of the exposure of 601 drug in the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>The proportional constant between the amount of 601 drug in the body and the blood concentration when the 601 drug achieves the dynamic balance in the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>Clearance rate of drug 601 from the central ventricle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>The average length of time that the 601 drug stays in the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>the ratio of the amount of elimination of 601 drug from the body per unit time to the total amount in the body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>Detection of VEGF concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>From Day 0 up to 56/112 days</time_frame>
    <description>Development of Anti-drug antibodies (ADA) after IVT injection of 601</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRT</measure>
    <time_frame>From Day 0 up to 56/364 days</time_frame>
    <description>Changes in central retina thickness (CRT) at all time points compared to the baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diseased region</measure>
    <time_frame>From Day 0 up to 56/364 days</time_frame>
    <description>Changes in the diseased region at all time points compared to the baseline</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">67</enrollment>
  <condition>Wet Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>601 dose level 1 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>601 dose level 2 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>601 dose level 3 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>601 dose level 4 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>601 dose level 5 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>601 dose level 6 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug 601</intervention_name>
    <description>Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;</description>
    <arm_group_label>601 dose level 1 treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug 601</intervention_name>
    <description>Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once;</description>
    <arm_group_label>601 dose level 2 treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug 601</intervention_name>
    <description>Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once;</description>
    <arm_group_label>601 dose level 3 treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug 601</intervention_name>
    <description>Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;</description>
    <arm_group_label>601 dose level 4 treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug 601</intervention_name>
    <description>Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.</description>
    <arm_group_label>601 dose level 5 treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug 601</intervention_name>
    <description>Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.</description>
    <arm_group_label>601 dose level 6 treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign informed consent form and willing to be visited at the time specified in the&#xD;
             trial;&#xD;
&#xD;
          2. Age ≥45 years and age ≤ 80 years;&#xD;
&#xD;
          3. The study eye must meet the following criteria:&#xD;
&#xD;
               -  Diagnosis of wAMD;&#xD;
&#xD;
               -  The presence of an primary or recurrent active choroidal neovascular (CNV)&#xD;
                  lesions in subfovea and para-fovea secondary to AMD;&#xD;
&#xD;
               -  Total area of all types of lesions ≤30mm2 (12 optic disc areas)&#xD;
&#xD;
               -  Best EDTRS letter score between 19 and 78(Snellen equivalent of 20/400 to 20/32);&#xD;
&#xD;
               -  No optometric media opacity and pupil shrinkage.&#xD;
&#xD;
          4. Best EDTRS letter score ≥19 (Snellen equivalent of 20/400 or better) in the fellow&#xD;
             eyes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any of the following eye conditions:&#xD;
&#xD;
          1. Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis,&#xD;
             conjunctivitis);&#xD;
&#xD;
          2. History of vitreous hemorrhage in the study eye within 2 months before screening;&#xD;
&#xD;
          3. scarring, fibrosis, or atrophy below with fovea in the study eye;&#xD;
&#xD;
          4. Received any drug treatment for CNV within 120 days prior to screening;&#xD;
&#xD;
          5. History of any following surgery in the study eye (e.g. PDT, macular transposition,&#xD;
             Glaucoma filtration, subfoveal photocoagulation, vitrectomy and transpupular&#xD;
             hyperthermia, and other surgery at the submacular or others for AMD) within 3 months&#xD;
             before screening;&#xD;
&#xD;
          6. CNV in the study eye associated with other ocular diseases such as pathologic myopia,&#xD;
             eye trauma, etc&#xD;
&#xD;
          7. History or present of uncontrolled glaucoma, history of glaucoma filtering surgery in&#xD;
             the study eye;&#xD;
&#xD;
          8. Subretinal hemorrhage in the study eye, and the bleeding area ≥ 50% area of the total&#xD;
             lesion;&#xD;
&#xD;
          9. History of rhegmatogenous retinal detachment or macular hole retinal detachment (stage&#xD;
             3 or 4) , retinal detachment, retinal pigment epithelium tear or macular area traction&#xD;
             and macular area preretinal membrane and PCV in the study eye;&#xD;
&#xD;
         10. The study eye has no lens( except intraocular lens) or posterior capsular rupture of&#xD;
             the lens;&#xD;
&#xD;
             Any of the following general condition are present:&#xD;
&#xD;
         11. Medicines with toxicity to the lens are being used or may be used during the study&#xD;
             period;&#xD;
&#xD;
         12. History of allergy to fluorescein sodium and allergies to protein products for&#xD;
             treatment or diagnosis, history of allergy to more than two drugs and/or non-drug&#xD;
             factors, or suffering from allergic diseases now.&#xD;
&#xD;
         13. History of surgery within 1 months before screening; and/or unhealed wounds, ulcers or&#xD;
             fractures currently;&#xD;
&#xD;
         14. Suffering from systemic infections and requiring oral, intramuscular or intravenous&#xD;
             medication;&#xD;
&#xD;
         15. History of stroke, myocardial infarction within 6 months before screening;&#xD;
&#xD;
         16. Active diffuse intravascular coagulation and obvious bleeding tendency within 3 months&#xD;
             before screening;&#xD;
&#xD;
         17. Systemic immune diseases;&#xD;
&#xD;
         18. Uncontrolled blood pressure control ;&#xD;
&#xD;
         19. Diabetic patients with uncontrolled blood sugar;&#xD;
&#xD;
         20. Any uncontrolled clinical problems (such as severe mental, neurological,&#xD;
             cardiovascular, respiratory and other systemic diseases and malignant tumours);&#xD;
&#xD;
             Any of the following laboratory tests abnormalities(23-25):&#xD;
&#xD;
         21. Renal function impairment (Cr is 1.5 times higher than the upper limit of normal&#xD;
             values in the local laboratory) Liver dysfunction (ALT or AST is 2 times higher than&#xD;
             the upper limit of normal value in the local laboratory).&#xD;
&#xD;
         22. Abnormal coagulation function (prothrombin time &gt;= the upper limit of normal value for&#xD;
             3 seconds) and activated partial thromboplastin time &gt;= the upper limit of normal&#xD;
             value for 10 seconds);&#xD;
&#xD;
             Patients with childbearing age with any of the following conditions:&#xD;
&#xD;
         23. Those who do not use effective contraceptive measures;&#xD;
&#xD;
             The following are not excluded:&#xD;
&#xD;
         24. Pregnancy and lactation women (pregnancy is defined as urinary pregnancy test positive&#xD;
             in this study);&#xD;
&#xD;
             Any other conditions:&#xD;
&#xD;
         25. Participation in any other drug clinical trials (except vitamins and minerals) in the&#xD;
             past 1 month before screening ;&#xD;
&#xD;
         26. Researchers think it needs to be ruled out.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhang Ming, Ph.D</last_name>
    <phone>+86-028-85422452</phone>
    <email>zhangmingscu@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lu Fang</last_name>
    <phone>+86-028-85422452</phone>
    <email>lufang@medicail.com.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BeiJing Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dai Hong</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_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/NCT04468997
org study id: 3SGJ601-AMD
nct id: NCT04468997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multicenter study to evaluate the safety and tolerability in patients with wet Age-related
      macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF
      monoclonal antibody
According to the results of preclinical pharmacological research and clinical application of
      bevacizumab in ophthalmology Case, 601 will be developed as a drug candidate for the
      treatment of ocular diseases such as wAMD .Observe the safety and tolerability of the single
      and multiple doses of 601 in wAMD patients; study the pharmacokinetic characteristics of
      single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections
      with different doses in the treatment of patients with wAMD.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: DLT
time frame: From Day 0 up to Day 14
description: Incidence of dose-limiting toxicities up to the Day 14 visit
measure: MTD
time frame: From Day 0 up to Day 56/112.
description: Maximum tolerated dose
measure: Pharmacokinetic (PK) profile
time frame: From Day 0 up to 56/112 days
description: Study the change of 601 drug concentration in the blood with time by mathematical principles and methods
measure: Cmax
time frame: From Day 0 up to 56/112 days
description: The maximum blood concentration after 601 drug enters the bloodstream
measure: t1/2
time frame: From Day 0 up to 56/112 days
description: The half-life of drug 601, the time required for the terminal phase 601 drug concentration to drop by half
measure: AUC
time frame: From Day 0 up to 56/112 days
description: Area under the concentration-time curve, reflect the characteristics of the exposure of 601 drug in the body.
measure: Vd
time frame: From Day 0 up to 56/112 days
description: The proportional constant between the amount of 601 drug in the body and the blood concentration when the 601 drug achieves the dynamic balance in the body.
measure: CL
time frame: From Day 0 up to 56/112 days
description: Clearance rate of drug 601 from the central ventricle.
measure: MRT
time frame: From Day 0 up to 56/112 days
description: The average length of time that the 601 drug stays in the body.
measure: λz
time frame: From Day 0 up to 56/112 days
description: the ratio of the amount of elimination of 601 drug from the body per unit time to the total amount in the body
measure: Biomarker
time frame: From Day 0 up to 56/112 days
description: Detection of VEGF concentration.
measure: Immunogenicity
time frame: From Day 0 up to 56/112 days
description: Development of Anti-drug antibodies (ADA) after IVT injection of 601
measure: CRT
time frame: From Day 0 up to 56/364 days
description: Changes in central retina thickness (CRT) at all time points compared to the baseline
measure: diseased region
time frame: From Day 0 up to 56/364 days
description: Changes in the diseased region at all time points compared to the baseline
arm group label: 601 dose level 1 treatment
arm group type: Experimental
arm group label: 601 dose level 2 treatment
arm group type: Experimental
arm group label: 601 dose level 3 treatment
arm group type: Experimental
arm group label: 601 dose level 4 treatment
arm group type: Experimental
arm group label: 601 dose level 5 treatment
arm group type: Experimental
arm group label: 601 dose level 6 treatment
arm group type: Experimental
intervention type: Drug
intervention name: Drug 601
description: Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;
arm group label: 601 dose level 1 treatment
intervention type: Drug
intervention name: Drug 601
description: Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once;
arm group label: 601 dose level 2 treatment
intervention type: Drug
intervention name: Drug 601
description: Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once;
arm group label: 601 dose level 3 treatment
intervention type: Drug
intervention name: Drug 601
description: Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;
arm group label: 601 dose level 4 treatment
intervention type: Drug
intervention name: Drug 601
description: Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
arm group label: 601 dose level 5 treatment
intervention type: Drug
intervention name: Drug 601
description: Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
arm group label: 601 dose level 6 treatment
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhang Ming, Ph.D
phone: +86-028-85422452
email: zhangmingscu@126.com
last name: Lu Fang
phone: +86-028-85422452
email: lufang@medicail.com.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Macular Degeneration
sharing ipd: No