xml: <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/NCT05986877</url>
    </required_header>
    <id_info>
      <org_study_id>STSA-1201-01</org_study_id>
      <nct_id>NCT05986877</nct_id>
    </id_info>
    <brief_title>A Study of STSA-1201 in Healthy Subjects</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Single Ascending-Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STSA-1201 Injection in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Staidson (Beijing) Biopharmaceuticals Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Staidson (Beijing) Biopharmaceuticals 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>
        This study is a Phase Ia, randomized, double-blind, placebo-controlled, single dose, dose&#xD;
        escalation safety, tolerability, and pharmacokinetic study of STSA-1201 injection in healthy&#xD;
        subjects. A total of 44 healthy subjects were enrolled in four dosage groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the safety and tolerability of single subcutaneous administration of STSA-1201 in healthy adult subjects.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax).</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve over a dosing interval, from time 0 to time t (AUC0-t).</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of maximum concentration (Tmax).</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination half-life (t1/2).</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent clearance (CL/F).</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume of distribution (Vz/F).</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in concentration of anti-drug antibody.</measure>
      <time_frame>Day0 through Day84</time_frame>
      <description>To evaluate the immunogenicity of STSA-1201 in healthy subjects:</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>lowest dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8 subjects will be randomized to receive lowest dose of STSA-1201 or dose-matched placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>low dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12 subjects will be randomized to receive low dose of STSA-1201 or dose-matched placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>middle dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12 subjects will be randomized to receive middle dose of STSA-1201 or dose-matched placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>high dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12 subjects will be randomized to receive high dose of STSA-1201 or dose-matched placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>STSA-1201 Subcutaneous injection</intervention_name>
      <description>Subcutaneous injection</description>
      <arm_group_label>high dose group</arm_group_label>
      <arm_group_label>low dose group</arm_group_label>
      <arm_group_label>lowest dose group</arm_group_label>
      <arm_group_label>middle dose group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subcutaneous injection</description>
      <arm_group_label>high dose group</arm_group_label>
      <arm_group_label>low dose group</arm_group_label>
      <arm_group_label>lowest dose group</arm_group_label>
      <arm_group_label>middle dose group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy subjects, male or female, aged between 18 and 50 years, inclusive.&#xD;
  &#xD;
            -  Male subjects must have a weight range of 50.0 kg to 75.0 kg inclusive, and female&#xD;
               subjects must have a weight range of 45.0 kg to 75.0 kg inclusive. All subjects must&#xD;
               have a body mass index (BMI) of 19.0 to 26.0 kg/m^2 inclusive.&#xD;
  &#xD;
            -  Subjects (and their partners) must abstain from sperm/egg donation and commit to using&#xD;
               effective methods of birth control during the trial and for 6 months post-trial.&#xD;
  &#xD;
            -  Subjects must have a normal or clinically acceptable medical history, physical&#xD;
               examination, laboratory test results, chest X-ray and electrocardiogram (ECG).&#xD;
  &#xD;
            -  Subjects must fully understand the trial procedures, potential adverse reactions, and&#xD;
               sign the informed consent form (ICF).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with significant clinical disorders or conditions (including but not limited&#xD;
               to gastrointestinal, rental, liver, neurological, hematologic, endocrine, oncologic,&#xD;
               pulmonary, immunologic, psychiatric, or cardiovascular diseases) and subjects with&#xD;
               active or suspected infections (viral, fungal, or parasitic).&#xD;
  &#xD;
            -  Subjects who underwent major surgery within 2 months prior to screening.&#xD;
  &#xD;
            -  Subjects with allergic constitution (such as allergies to two or more drugs, foods,&#xD;
               and pollen) or potential allergy to the trial product/components.&#xD;
  &#xD;
            -  Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV&#xD;
               Ab), human immunodeficiency virus antibody (HIV Ab) or treponema pallidum antibody (TP&#xD;
               Ab).&#xD;
  &#xD;
            -  Subjects with Ig E levels exceeding the normal upper limit.&#xD;
  &#xD;
            -  Subjects who have smoked more than an average of 5 cigarettes per day within the 3&#xD;
               months prior to screening, or who are unable to abstain from using any tobacco or&#xD;
               nicotine-containing products during the trial.&#xD;
  &#xD;
            -  Subjects with a history of alcohol abuse (more than 14 units per week: 1 unit of&#xD;
               alcohol =360mL beer or 45mL spirits with 40% alcohol or 100mL wine) within the 6&#xD;
               months prior to screening, or unable to abstain during the trial, or failed alcohol&#xD;
               breath test.&#xD;
  &#xD;
            -  Subjects with drug abuse history (morphine, ketamine, THC, methamphetamine,&#xD;
               methylene-dioxymethamphetamine, cocaine) within 1 year prior to screening or those&#xD;
               testing positive for urine drug abuse screening.&#xD;
  &#xD;
            -  Subjects who donated or lost &gt; 400 mL blood within 3 months prior to screening,&#xD;
               received blood transfusions or products within 4 weeks prior to enrollment, or plan to&#xD;
               donate blood during the trial and 3 months post-trial.&#xD;
  &#xD;
            -  Subjects who participated in another clinical trial or received investigational&#xD;
               drugs/vaccines within 3 months prior to screening.&#xD;
  &#xD;
            -  Subjects who received biologicals or monoclonal antibodies within 3 months prior to&#xD;
               screening; subjects who used any medication (including prescription medications, over&#xD;
               the counter medications and herbal medicines) within 14 days prior to screening;&#xD;
               subjects previously treated with any drugs targeting thymic stromal lymphopoietin&#xD;
               (TSLP).&#xD;
  &#xD;
            -  Subjects consuming xanthine-rich foods/beverages (such as coffee, strong tea,&#xD;
               chocolate) or those that affect drug absorption, distribution, metabolism, and&#xD;
               excretion within 48 hours prior to administration.&#xD;
  &#xD;
            -  Subjects who used long-acting estrogen or progestogen injections or implants within 6&#xD;
               months prior to screening or short-acting contraceptives within 30 days prior to the&#xD;
               trial.&#xD;
  &#xD;
            -  Female subjects who test positive for serum human chorionic gonadotropin (HCG) or have&#xD;
               abnormal HCG levels exceeding the normal upper limit.&#xD;
  &#xD;
            -  Female subjects who are pregnant or lactating.&#xD;
  &#xD;
            -  Subjects with venipuncture intolerance, history of transfusion issues, or blood/&#xD;
               needle-phobia.&#xD;
  &#xD;
            -  Subjects with any condition or circumstance which, in the opinion of the Investigator,&#xD;
               may compromise the ability to provide informed consent, comply with the study&#xD;
               protocol, potentially influence study outcomes, jeopardize their own safety, or any&#xD;
               other situation deemed unsuitable for study participation by the investigator.&#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>
    <overall_official>
      <last_name>Xinghe Wang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Shijitan Hospital, Capital Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Min Liu</last_name>
      <phone>+86-18519789088</phone>
      <email>liumin@staidson.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Shijitan Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>102600</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xinghe Wang</last_name>
        <phone>010-63926401</phone>
        <email>wangxh@bjsjth.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986877
  org study id: STSA-1201-01
  nct id: NCT05986877
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a Phase Ia, randomized, double-blind, placebo-controlled, single dose, dose
        escalation safety, tolerability, and pharmacokinetic study of STSA-1201 injection in healthy
        subjects. A total of 44 healthy subjects were enrolled in four dosage groups.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
  time frame: Day0 through Day84
  description: To evaluate the safety and tolerability of single subcutaneous administration of STSA-1201 in healthy adult subjects.
  measure: Maximum plasma concentration (Cmax).
  time frame: Day0 through Day84
  description: To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
  measure: Area under the plasma concentration-time curve over a dosing interval, from time 0 to time t (AUC0-t).
  time frame: Day0 through Day84
  description: To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
  measure: Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).
  time frame: Day0 through Day84
  description: To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
  measure: Time of maximum concentration (Tmax).
  time frame: Day0 through Day84
  description: To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
  measure: Elimination half-life (t1/2).
  time frame: Day0 through Day84
  description: To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
  measure: Apparent clearance (CL/F).
  time frame: Day0 through Day84
  description: To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
  measure: Apparent volume of distribution (Vz/F).
  time frame: Day0 through Day84
  description: To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1201 in healthy adult subjects.
  measure: Change from baseline in concentration of anti-drug antibody.
  time frame: Day0 through Day84
  description: To evaluate the immunogenicity of STSA-1201 in healthy subjects:
  arm group label: lowest dose group
  arm group type: Experimental
  description: 8 subjects will be randomized to receive lowest dose of STSA-1201 or dose-matched placebo.
  arm group label: low dose group
  arm group type: Experimental
  description: 12 subjects will be randomized to receive low dose of STSA-1201 or dose-matched placebo.
  arm group label: middle dose group
  arm group type: Experimental
  description: 12 subjects will be randomized to receive middle dose of STSA-1201 or dose-matched placebo.
  arm group label: high dose group
  arm group type: Experimental
  description: 12 subjects will be randomized to receive high dose of STSA-1201 or dose-matched placebo.
  intervention type: Drug
  intervention name: STSA-1201 Subcutaneous injection
  description: Subcutaneous injection
  arm group label: high dose group
  arm group label: low dose group
  arm group label: lowest dose group
  arm group label: middle dose group
  intervention type: Drug
  intervention name: Placebo
  description: Subcutaneous injection
  arm group label: high dose group
  arm group label: low dose group
  arm group label: lowest dose group
  arm group label: middle dose group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xinghe Wang, MD
  role: Principal Investigator
  affiliation: Beijing Shijitan Hospital, Capital Medical University
  last name: Min Liu
  phone: +86-18519789088
  email: liumin@staidson.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor