<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/NCT03288636</url>
  </required_header>
  <id_info>
    <org_study_id>ASC-ASC16-I-CTP-02</org_study_id>
    <nct_id>NCT03288636</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China</brief_title>
  <official_title>A Phase I Study to Assess the Pharmacokinetics and Safety of Single Dose of Ravidasvir and Danoprevir/r and Repeated Doses of Ravidasvir in Combination With Danoprevir/r in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascletis Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascletis Pharmaceuticals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of&#xD;
      Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r&#xD;
      in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">October 28, 2017</completion_date>
  <primary_completion_date type="Actual">September 14, 2017</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>Parallel 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</measure>
    <time_frame>40 days</time_frame>
    <description>Incidence of adverse events</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>HCV</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PKGroup:&#xD;
Ravidasvir + Danoprevir/ Ritonavir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Group:&#xD;
Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Danoprevir</intervention_name>
    <description>Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <description>Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ravidasvir</intervention_name>
    <description>Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>ASC16(RDV)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-45 years old;&#xD;
&#xD;
          -  Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the&#xD;
             range of 19~28kg/m2&#xD;
&#xD;
          -  Healthy men or women based on history, physical examination, laboratory examination&#xD;
             and ECG.&#xD;
&#xD;
          -  Female subjects should be surgically sterilized (bilateral tubal ligation, bilateral&#xD;
             ovariectomy or hysterectomy); or are willing to use at least one of the following&#xD;
             contraceptive methods within 30 days of the first administration of the study drug&#xD;
             until the last administration: I Male partner vas deferens ligation; II. Non-hormonal&#xD;
             contraceptive methods: intrauterine contraceptives, condoms, contraceptive sponges,&#xD;
             septa, vaginal ring containing sizing gel or cream.&#xD;
&#xD;
          -  Male subjects should be surgically sterilized; or are willing to use at least one of&#xD;
             the following contraceptive methods within 30 days from the first administration of&#xD;
             the study to the last administration: I. Female partners abstinence during the study&#xD;
             period (including no donation): II. Compounds use hormonal contraceptives (oral,&#xD;
             vaginal, parenteral or transdermal); III. Subjects and / or their female partners use&#xD;
             non-hormonal contraceptive methods: condoms, contraceptive sponges, membranes,&#xD;
             intrauterine devices, Fine gel or cream of the vaginal ring.&#xD;
&#xD;
          -  If female, the pregnancy test result should be negative during the screening period.&#xD;
&#xD;
          -  Voluntary to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of cardiovascular disease, respiratory disease, endocrine and&#xD;
             metabolic system disease, urinary system, digestive system, hematological system&#xD;
             diseases, nervous system or Psychiatric diseases, and acute or chronic infectious&#xD;
             disease and malignant tumor.&#xD;
&#xD;
          -  A history of drug or food allergy.&#xD;
&#xD;
          -  Positive test in any of the HBsAg、HCV Ab、HIV Ab and Syphilis Ab.&#xD;
&#xD;
          -  Any of the AST、ALT、ALP、TBIL and DBIL exceed the upper limits of normal, or other&#xD;
             laboratory test results exceeding the normal range and judged by the investigator to&#xD;
             be clinically significant.&#xD;
&#xD;
          -  History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other&#xD;
             surgeries that could disturb gastrointestinal motility and PH absorption.&#xD;
&#xD;
          -  Female who were during pregnancy, breastfeeding, period and unwilling to take reliable&#xD;
             birth control method.&#xD;
&#xD;
          -  Female partners were fertile and unwilling to take reliable contraceptive measures.&#xD;
&#xD;
          -  Others as specified in the detailed protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The first hospital of Zhejiang province</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>January 14, 2018</last_update_submitted>
  <last_update_submitted_qc>January 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</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/NCT03288636
org study id: ASC-ASC16-I-CTP-02
nct id: NCT03288636
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of
      Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r
      in healthy volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of adverse events
time frame: 40 days
description: Incidence of adverse events
arm group label: Experimental
arm group type: Experimental
description: PKGroup:
Ravidasvir + Danoprevir/ Ritonavir
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Group:
Placebo
intervention type: Drug
intervention name: Danoprevir
description: Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
arm group label: Experimental
intervention type: Drug
intervention name: Ritonavir
description: Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
arm group label: Experimental
intervention type: Drug
intervention name: Ravidasvir
description: Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
arm group label: Experimental
other name: ASC16(RDV)
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Ritonavir
sharing ipd: No