<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/NCT04503733</url>
  </required_header>
  <id_info>
    <org_study_id>GETA_MAD_01</org_study_id>
    <nct_id>NCT04503733</nct_id>
  </id_info>
  <brief_title>A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gmax Biopharm LLC.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gmax Biopharm LLC.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Placebo-Controlled, Double-blind, Dose Escalation Study to Assess Safety,&#xD;
      Efficacy and Pharmacokinetics of GMA301 Injection in Subjects with Pulmonary Arterial&#xD;
      Hypertension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug: Q4W GMA301 IV injections (300 mg) Drug: Q4W GMA301 IV injections (600 mg) Drug: Q4W&#xD;
      GMA301 IV injections (1000 mg) Drug: Q4W GMA301 IV injections (1800 mg) Other: Q4W placebo IV&#xD;
      injections&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 22, 2020</start_date>
  <completion_date type="Anticipated">June 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 26, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.</measure>
    <time_frame>Through study completion (up to 22 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (Area under the serum concentration- time curve from time zero to the last measurable concentration)</measure>
    <time_frame>Through study completion (up to 22 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of GMA301 treatment effect at Week 12 versus baseline regarding the pulmonary vascular resistance (PVR) based on right heart catheterization (RHC)</measure>
    <time_frame>Baseline to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparing 6MWT distance</measure>
    <time_frame>Baseline to Week 12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in REVEAL 2.0 risk score at Week 12 compared with baseline</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Calculated risk scores can range from 0 (lowest risk) to 23 (highest risk).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>Q4W GMA301 IV injections (300 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Q4W GMA301 IV injections (300 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.&#xD;
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Q4W GMA301 IV injections (600 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Q4W GMA301 IV injections (600 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.&#xD;
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Q4W GMA301 IV injections (1000 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Q4W GMA301 IV injections (1000 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.&#xD;
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Q4W GMA301 IV injections (1800 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Q4W GMA301 IV injections (1800 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.&#xD;
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Q4W GMA301 IV injections (300 mg)</intervention_name>
    <description>Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.</description>
    <arm_group_label>Q4W GMA301 IV injections (300 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Q4W GMA301 IV injections (600 mg)</intervention_name>
    <description>Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.</description>
    <arm_group_label>Q4W GMA301 IV injections (600 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Q4W GMA301 IV injections (1000 mg)</intervention_name>
    <description>Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.</description>
    <arm_group_label>Q4W GMA301 IV injections (1000 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Q4W GMA301 IV injections (1800 mg)</intervention_name>
    <description>Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.</description>
    <arm_group_label>Q4W GMA301 IV injections (1800 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Q4W placebo IV injections</intervention_name>
    <description>Placebo is indistinguishable from GMA301.</description>
    <arm_group_label>Q4W GMA301 IV injections (1000 mg)</arm_group_label>
    <arm_group_label>Q4W GMA301 IV injections (1800 mg)</arm_group_label>
    <arm_group_label>Q4W GMA301 IV injections (300 mg)</arm_group_label>
    <arm_group_label>Q4W GMA301 IV injections (600 mg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Subjects must meet all of the following criteria:&#xD;
&#xD;
          1. Male or female, aged 18 to 75 years inclusive&#xD;
&#xD;
          2. WHO Group 1 PAH related to one of the following conditions:&#xD;
&#xD;
               1. Idiopathic&#xD;
&#xD;
               2. Heritable&#xD;
&#xD;
               3. Drugs or toxins-induced&#xD;
&#xD;
               4. Associated with connective tissue disease&#xD;
&#xD;
               5. Associated with congenital heart disease if subjects underwent surgical&#xD;
                  correction more than 12 months before Screening&#xD;
&#xD;
          3. Symptoms due to PAH are consistent with WHO functional class II- III&#xD;
&#xD;
          4. Have not taken endothelin receptor antagonists (ERAs) within 3 months before&#xD;
             Randomization&#xD;
&#xD;
          5. Has been taking at least one oral PAH targeted drug that has been approved by local&#xD;
             guidelines for at least 3 months before Screening with stable dosage and the disease&#xD;
             did not worsen during this period per Investigator's judgment&#xD;
&#xD;
          6. Right heart catheterization (RHC) result meets below criteria when Screening:&#xD;
&#xD;
               1. Mean pulmonary arterial pressure (PAP) ≥25 mmHg&#xD;
&#xD;
               2. Pulmonary vascular resistance (PVR) &gt;3 Woods units&#xD;
&#xD;
               3. PA wedge pressure (PAWP) ≤15 mmHg&#xD;
&#xD;
             If a subject has undergone RHC within 3 months before Screening, the waveform results&#xD;
             will serve as baseline data only if they meet the entry criteria and the RHC at&#xD;
             Screening will not be repeated. In case PAWP cannot be well measured during RHC, left&#xD;
             ventricular end diastolic pressure will be tested by left heart catheterization.&#xD;
&#xD;
          7. Has a six-minute walk test (6MWT) with distance between 150 to 450 meters at Screening&#xD;
&#xD;
          8. The dosage of digitalis drugs or L-arginine supplementation must be stable for at&#xD;
             least 1 month before Screening, if applicable.&#xD;
&#xD;
          9. No new use of an IV diuretic, cardiotonic (positive inotropic agents), or vasoactive&#xD;
             drug within 30 days before Screening&#xD;
&#xD;
         10. Both male and female subjects agree to use 2 medically acceptable methods of&#xD;
             contraception (Appendix 4) throughout the entire study period from informed consent&#xD;
             signing to 90 days after last dose, if the possibility of conception exists. Medically&#xD;
             acceptable methods of contraception include oral, implantable, or injectable&#xD;
             contraceptives (starting 2 months before dosing); diaphragm with vaginal spermicide;&#xD;
             intrauterine device; condom and partner using vaginal spermicide; and surgical&#xD;
             sterilization (6 months after surgery). Women who are surgically sterile or those who&#xD;
             are postmenopausal for at least 2 years are not considered to be of childbearing&#xD;
             potential. Eligible male and female subjects must agree not to participate in a&#xD;
             conception process (i.e. active attempt to become pregnant or to impregnate, sperm&#xD;
             donation, in vitro fertilization) during the study and for 90 days after the last dose&#xD;
             of study drug.&#xD;
&#xD;
         11. Body weight no less than 40 kg at Screening&#xD;
&#xD;
         12. Able to understand and willing to sign the Informed Consent Form (ICF) and comply with&#xD;
             the study procedures.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Subjects who me et any of the following criteria will not be allowed to participate in this&#xD;
        study:&#xD;
&#xD;
          1. Diagnosed with WHO Group II, III, IV, V of PH&#xD;
&#xD;
          2. Use of calcium channel blockers within 1 month prior to Screening&#xD;
&#xD;
          3. Systolic blood pressure (SBP) &gt;160 mmHg or diastolic blood pressure (DBP) &gt;100 mmHg at&#xD;
             Screening&#xD;
&#xD;
          4. SBP &lt;90 mmHg at Screening&#xD;
&#xD;
          5. Pulmonary function test: FEV1 &lt;60% of predicted, TLC &lt;60% of predicted, DLCO &lt;60% of&#xD;
             predicted&#xD;
&#xD;
          6. History of pulmonary embolism as judged by the Investigator&#xD;
&#xD;
          7. Uncontrolled sleep apnea at the discretion of the Investigator&#xD;
&#xD;
          8. Limited full participation in the 6MWT due to arthritic, neuromuscular, vascular or&#xD;
             other diseases unrelated to PAH&#xD;
&#xD;
          9. History of acute cardiovascular and/or cerebrovascular events within 6 months before&#xD;
             Screening&#xD;
&#xD;
         10. Echocardiogram (ECHO) demonstrating at least one of the following at Screening:&#xD;
&#xD;
               1. LVEF &lt;50%&#xD;
&#xD;
               2. Mean end-diastolic left ventricular septal and posterior wall thickness of &gt;12 mm&#xD;
&#xD;
               3. Left atrial (LA) area on apical 4 chamber view &gt;20 cm2&#xD;
&#xD;
               4. LA volume &gt;55 mL&#xD;
&#xD;
               5. LA volume index &gt;34 mL/m2&#xD;
&#xD;
               6. Significant valvular heart disease including moderate or severe mitral or aortic&#xD;
                  stenosis with an aortic valve area &lt;1.0 cm2 or mitral valve area &lt;1.5 cm2,&#xD;
                  greater than moderate aortic or mitral regurgitation, greater than moderate&#xD;
                  tricuspid or pulmonic stenosis&#xD;
&#xD;
         11. Restrictive, dilated or hypertrophic cardiomyopathy or constrictive pericarditis&#xD;
&#xD;
         12. Using non-oral prostacyclin when Screening&#xD;
&#xD;
         13. Laboratory parameters during Screening:&#xD;
&#xD;
               1. Baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2&#xD;
                  times the upper limit of normal (ULN) or total bilirubin ≥1.5 times ULN&#xD;
&#xD;
               2. Estimated glomerular filtration rate (eGFR) &lt;60 mL/min by Cockcroft-Gault formula&#xD;
&#xD;
                  Online calculation available from&#xD;
                  https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc&#xD;
&#xD;
                  Cockcroft-Gault formula (1973):&#xD;
&#xD;
                  Male: CCr=((l40-Age) × Weight)/(72×SCr)&#xD;
&#xD;
                  Female: CCr={((l40-Age) × Weight)/(72×SCr)}× 0.85&#xD;
&#xD;
                  CCr (creatinine clearance rate) = mL/min&#xD;
&#xD;
                  Age = year&#xD;
&#xD;
                  Weight = Kg&#xD;
&#xD;
                  SCr (serum creatinine) = mg/dL&#xD;
&#xD;
               3. Hemoglobin concentration ≤100 g/L at Screening&#xD;
&#xD;
         14. QTc interval by Fridericia's criteria (QTcF) ≥500 msec at Screening&#xD;
&#xD;
         15. Malignancy within 5 years before Screening visit (with the exception of localized&#xD;
             non-metastatic basal cell carcinoma of the skin, non-metastatic carcinoma of the&#xD;
             prostate or in-situ carcinoma of the cervix excised with curative results)&#xD;
&#xD;
         16. Alcohol or drug abuse within 1 year before Screening&#xD;
&#xD;
         17. A psychiatric, addictive or other disorder that compromises the ability to give&#xD;
             informed consent for participating in this study&#xD;
&#xD;
         18. History of organ transplantation&#xD;
&#xD;
         19. Pregnant or nursing females&#xD;
&#xD;
         20. History of HIV&#xD;
&#xD;
         21. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or HIV&#xD;
             antibody (HIV-ab)&#xD;
&#xD;
         22. Enrolled in another interventional study within 30 days before Screening&#xD;
&#xD;
         23. Any condition that, in the opinion of the Investigator, prevents a potential subject&#xD;
             from safely participating in the study&#xD;
&#xD;
         24. Start a new exercise program or participate in any unusually strenuous physical&#xD;
             exertion within 6 weeks prior to Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hua Yao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lan Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Pulmonary Hospital, Shanghai, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Huang</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zaixin Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fenling Fan</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhicheng Jing</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital - Dongcheng District</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aaron Waxman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianjun Wu</last_name>
    <phone>+8618358737112</phone>
    <email>jianjunwu@gmaxbiopharm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aaron Waxman</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital - Dongcheng District</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhicheng Jing</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital, Central South University</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zaixin Yu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Huang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hua Yao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lan Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xian</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fenling Fan</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>December 29, 2021</last_update_submitted>
  <last_update_submitted_qc>December 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</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>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT04503733/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT04503733/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04503733
org study id: GETA_MAD_01
nct id: NCT04503733
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
A Randomized, Placebo-Controlled, Double-blind, Dose Escalation Study to Assess Safety,
      Efficacy and Pharmacokinetics of GMA301 Injection in Subjects with Pulmonary Arterial
      Hypertension
Drug: Q4W GMA301 IV injections (300 mg) Drug: Q4W GMA301 IV injections (600 mg) Drug: Q4W
      GMA301 IV injections (1000 mg) Drug: Q4W GMA301 IV injections (1800 mg) Other: Q4W placebo IV
      injections
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
time frame: Through study completion (up to 22 weeks)
measure: Pharmacokinetics (Area under the serum concentration- time curve from time zero to the last measurable concentration)
time frame: Through study completion (up to 22 weeks)
measure: Comparison of GMA301 treatment effect at Week 12 versus baseline regarding the pulmonary vascular resistance (PVR) based on right heart catheterization (RHC)
time frame: Baseline to Week 12
measure: Comparing 6MWT distance
time frame: Baseline to Week 12
measure: Changes in REVEAL 2.0 risk score at Week 12 compared with baseline
time frame: Baseline to Week 12
description: Calculated risk scores can range from 0 (lowest risk) to 23 (highest risk).
arm group label: Q4W GMA301 IV injections (300 mg)
arm group type: Experimental
description: Drug: Q4W GMA301 IV injections (300 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
arm group label: Q4W GMA301 IV injections (600 mg)
arm group type: Experimental
description: Drug: Q4W GMA301 IV injections (600 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
arm group label: Q4W GMA301 IV injections (1000 mg)
arm group type: Experimental
description: Drug: Q4W GMA301 IV injections (1000 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
arm group label: Q4W GMA301 IV injections (1800 mg)
arm group type: Experimental
description: Drug: Q4W GMA301 IV injections (1800 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
intervention type: Drug
intervention name: Q4W GMA301 IV injections (300 mg)
description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
arm group label: Q4W GMA301 IV injections (300 mg)
intervention type: Drug
intervention name: Q4W GMA301 IV injections (600 mg)
description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
arm group label: Q4W GMA301 IV injections (600 mg)
intervention type: Drug
intervention name: Q4W GMA301 IV injections (1000 mg)
description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
arm group label: Q4W GMA301 IV injections (1000 mg)
intervention type: Drug
intervention name: Q4W GMA301 IV injections (1800 mg)
description: Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
arm group label: Q4W GMA301 IV injections (1800 mg)
intervention type: Other
intervention name: Q4W placebo IV injections
description: Placebo is indistinguishable from GMA301.
arm group label: Q4W GMA301 IV injections (1000 mg)
arm group label: Q4W GMA301 IV injections (1800 mg)
arm group label: Q4W GMA301 IV injections (300 mg)
arm group label: Q4W GMA301 IV injections (600 mg)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hua Yao
role: Principal Investigator
affiliation: Guangdong Provincial People's Hospital
last name: Lan Wang
role: Principal Investigator
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
last name: Wei Huang
role: Principal Investigator
affiliation: First Affiliated Hospital of Chongqing Medical University
last name: Zaixin Yu
role: Principal Investigator
affiliation: Xiangya Hospital of Central South University
last name: Fenling Fan
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Zhicheng Jing
role: Principal Investigator
affiliation: Peking Union Medical College Hospital - Dongcheng District
last name: Aaron Waxman
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Jianjun Wu
phone: +8618358737112
email: jianjunwu@gmaxbiopharm.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
provided document: 
provided document: 