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/NCT06034015</url>
    </required_header>
    <id_info>
      <org_study_id>YHGT-PN-02</org_study_id>
      <nct_id>NCT06034015</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers</brief_title>
    <official_title>A Phase 1, Two-Part, Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of Single Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers (Part A) and Multiple Ascending Doses of APL-1501 ER Capsules Compared to APL-1202 IR Tablets in Healthy Volunteers (Part B)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu Yahong Meditech Co., Ltd aka Asieris</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu Yahong Meditech Co., Ltd aka Asieris</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>
        This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study&#xD;
        conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER&#xD;
        capsules in comparison to APL-1202 IR tablets.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will have 2 parts: Each study part will comprise 2 dosing periods with a 72-hour&#xD;
        washout period in between:&#xD;
  &#xD;
        Period 1: APL-1202 IR tablet dosing and Period 2: APL-1501 ER capsule dosing.&#xD;
  &#xD;
        In Part A dosing will be single day/single dosing for the APL-1202 IR tablets, and single&#xD;
        day/single dosing the APL-1501 ER capsules with 24 participants in 3 sequential cohorts,&#xD;
        Cohorts A1, A2, and A3. Each cohort will enrol 8 participants, with male to female&#xD;
        participants in a 1:1 ratio. In Period 1/Day 1, participants in all cohorts will be dosed&#xD;
        with single dose of 375 mg APL-1202 IR tablets which will followed by a washout period of at&#xD;
        least 72 hours, after which participants will be dosed with single dose of APL-1501 ER&#xD;
        capsules in Period 2/Day 4, .&#xD;
  &#xD;
        In Part B dosing will be multi-day/TID dosing for the APL-1202 IR tablets, and multi-day/BID&#xD;
        dosing the APL-1501 ER capsules with 24 participants in 2 sequential cohorts, Cohorts B1 and&#xD;
        B2. Each cohort will enrol 12 participants, with male to female participants in a 1:1 ratio&#xD;
        and in each of the 2 study periods, participants will be administered IP for 5 days. In&#xD;
        period 1, participants will administered with APL-1202 IR tablet (TID) on Day 1, Day 2, Day&#xD;
        3, Day 4, and Day 5 and period 2 with APL-1501 ER capsule (BID) dosing on Day 9, Day 10, Day&#xD;
        11, Day 12, and morning of Day 13.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 9, 2023</start_date>
    <completion_date type="Anticipated">February 7, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 19, 2024</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>Adverse Events (AEs)</measure>
      <time_frame>Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up</time_frame>
      <description>Number of participants with AEs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serious Adverse Events (SAEs)</measure>
      <time_frame>Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up</time_frame>
      <description>Number of participants with SAEs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatement Emergent Adverse Events (TEAEs)</measure>
      <time_frame>Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up</time_frame>
      <description>Number of participants with TEAEs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PK parameters: area under the curve (AUC)</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>Area under the curve (AUC) of APL-1501 ER capsules and APL-1202 IR Tablets</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameters: maximum concentration (Cmax)</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>maximum concentration (Cmax), of APL-1501 ER capsules and APL-1202 IR Tablets</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameters: Tmax</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>Tmax of APL-1501 ER capsules and APL-1202 IR Tablets</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameters: half-life (t1/2)</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>apparent t1/2 of APL-1501 ER capsules and APL-1202 IR Tablets</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine PK parameters: Renal clearance (CLr)</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>Urine concentration of APL-1202 Tablets.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine PK parameters: Total amount of the APL-1202 excreted in urine from time t1 to t2 hours (Aet1-t2)</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>Urine concentration of APL-1202 Tablets.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Parameters: Apparent total plasma clearance (CL/F)</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>CL/F of APL-1501 ER capsules and APL-1202 IR Tablets</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Parameters: Apparent terminal volume of distribution (Vz/F)</measure>
      <time_frame>up to 120 hours post dose in each treatment period</time_frame>
      <description>Vz/F of APL-1501 ER capsules and APL-1202 IR Tablets</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Bladder Cancer</condition>
    <arm_group>
      <arm_group_label>Part A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>APL-1202 and APL-1501 (Single ascending dose)</intervention_name>
      <description>Period 1 drug adminstration (APL-1202 IR tablet , single dose of 375mg will be administered orally on Day 1; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered as single dose on Day 4.</description>
      <arm_group_label>Part A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>APL-1202 and APL-1501 (Multiple Ascending dose)</intervention_name>
      <description>Period 1 drug adminstration (APL-1202 IR of 375mg will be administered thrice a day (TID) orally from Day 1 to Day 5; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered twice daily (BID) from Day 9 to 13.</description>
      <arm_group_label>Part B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy male or female 18 to 65 years of age (inclusive at the time of informed&#xD;
               consent).&#xD;
  &#xD;
            2. In good general health, with no significant medical history and no clinically&#xD;
               significant abnormalities on physical examination, 12-lead ECG, vital signs and&#xD;
               oximetry measurements at Screening and/or before the first administration of&#xD;
               Investigational Products (IP), as determined by the Principal Investigator or&#xD;
               designee.&#xD;
  &#xD;
            3. Clinical laboratory values within normal range as specified by the testing laboratory,&#xD;
               at Screening and/or before the first administration of IP unless deemed not clinically&#xD;
               significant (NCS) by the Principal Investigator or designee.&#xD;
  &#xD;
            4. Body-mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weight ≥ 50 kg.&#xD;
  &#xD;
            5. Current non-smoker or casual smoker who used no more than 5 cigarettes (or equivalent&#xD;
               quantity of any other nicotine-containing products eg, snuff, chewing tobacco, cigars,&#xD;
               cigarettes, pipes, e-cigarettes [Vaping] etc.) per week for 3 months prior to&#xD;
               Screening. Participants must abstain from smoking and abstain from using&#xD;
               nicotine-containing products (eg, nicotine chewing gum, nicotine plasters, or other&#xD;
               product used for smoking cessation) for 2 weeks prior to admission and throughout the&#xD;
               study period, and test negative at Screening and on Day -1 for urinary cotinine.&#xD;
  &#xD;
            6. No relevant dietary restrictions.&#xD;
  &#xD;
            7. Females must not be pregnant or lactating, and must use acceptable, highly effective&#xD;
               double contraception from Screening until 30 days after study completion, including&#xD;
               the Follow-up period.&#xD;
  &#xD;
            8. Males must be surgically sterile (&gt; 90 days since vasectomy with no viable sperm), or&#xD;
               if engaged in sexual relations with a women of child bearing potential (WOCBP), his&#xD;
               partner must be either surgically sterile (eg, hysterectomy, bilateral salpingectomy,&#xD;
               bilateral oophorectomy), or use an acceptable, highly effective contraceptive method&#xD;
               (see Section 7.3.3) from Screening until 90 days after study completion, including the&#xD;
               Follow-up period.&#xD;
  &#xD;
            9. Able and willing to attend the necessary visits to the study site.&#xD;
  &#xD;
           10. Able and willing to provide written informed consent after the nature of the study has&#xD;
               been explained and prior to the commencement of any study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Underlying physical or psychological medical condition that, in the opinion of the PI,&#xD;
               would make it unlikely for the participant to comply with the protocol or complete the&#xD;
               study per protocol.&#xD;
  &#xD;
            2. Receipt of blood products, or significant blood loss deemed to be CTCAE Grade 3 or&#xD;
               Grade 4 within 6 weeks prior to the first administration of IP.&#xD;
  &#xD;
            3. Plasma donation within 7 days prior to the first administration of IP, or&#xD;
               platelet/blood donation within 4 weeks prior to the first administration of IP&#xD;
  &#xD;
            4. Fever (body temperature &gt; 38°C) or symptomatic viral or bacterial infection within 2&#xD;
               weeks prior to the first administration of IP.&#xD;
  &#xD;
            5. Poor pill swallowing ability.&#xD;
  &#xD;
            6. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its&#xD;
               constituents, including lactose intolerance/allergy.&#xD;
  &#xD;
            7. History of malignancy, except for non-melanoma skin cancer, excised more than 1 year&#xD;
               prior to Screening and cervical intraepithelial neoplasia that has been successfully&#xD;
               cured more than 5 years prior to Screening.&#xD;
  &#xD;
            8. History or presence of a condition associated with significant immunosuppression.&#xD;
  &#xD;
            9. History of life-threatening infection (eg, meningitis). Severe infections within 4&#xD;
               weeks prior to the first administration of IP including but not limited to&#xD;
               hospitalisation for complications of infection, bacteraemia, or severe pneumonia.&#xD;
  &#xD;
           10. Infections requiring parenteral antibiotics within 6 months prior to the first&#xD;
               administration of IP.&#xD;
  &#xD;
           11. Vaccination with a live vaccine within 4 weeks prior to the first administration of&#xD;
               IP. COVID-19 or influenza can be exempted.&#xD;
  &#xD;
           12. Exposure to any significantly immune suppressing drug (including experimental&#xD;
               therapies as part of a clinical study) within 4 months prior to the first&#xD;
               administration of IP or 5-half-lives, whichever is longer.&#xD;
  &#xD;
           13. Positive test for hepatitis C virus antibody (HCVAb), hepatitis B virus surface&#xD;
               antigen (HBsAg), human Immunodeficiency virus (HIV) antibody, or COVID-19 at Screening&#xD;
               and Day-1.&#xD;
  &#xD;
           14. History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test at Screening or 2&#xD;
               successive indeterminate QuantiFERON-TB Gold test results.&#xD;
  &#xD;
           15. Positive toxicology screening panel (urine test including qualitative identification&#xD;
               of barbiturates, tetrahydrocannabinol, amphetamines, benzodiazepines, opiates, cocaine&#xD;
               and tricyclic antidepressants), or alcohol breath test at Screening and Day-1.&#xD;
  &#xD;
           16. History of substance abuse or dependency or history of recreational intravenous drug&#xD;
               use over the last 5 years (by self-declaration).&#xD;
  &#xD;
           17. Regular alcohol consumption defined as &gt; 10 standard drinks per week (where 1 standard&#xD;
               drink = 360 mL of beer, 45 mL of 40% spirit or a 150 mL glass of wine) or &gt; 4 standard&#xD;
               drinks on any single day. Participant is unwilling to abstain from alcohol beginning&#xD;
               48 hours prior to the first administration of IP and for the duration of the study.&#xD;
  &#xD;
           18. Use of any IP or investigational medical device within 30 days prior to the first&#xD;
               administration of IP, or 5 half-lives of the product (whichever is the longest), or&#xD;
               participation in more than 4 investigational drug studies within 1 year prior to the&#xD;
               first administration of IP.&#xD;
  &#xD;
           19. Use of (or anticipated use of) any prescription drugs or over-the-counter (OTC)&#xD;
               medication, herbal remedies, supplements or vitamins 2 weeks prior to the first&#xD;
               administration of IP and during the course of the study without prior approval of the&#xD;
               PI and Medical Monitor (MM). Simple analgesia (paracetamol, nonsteroidal&#xD;
               anti-inflammatory drug ) may be permitted at the discretion of the PI. The use of&#xD;
               hormonal contraception, oral contraceptive pills, long-acting implantable hormones,&#xD;
               injectable hormones, a vaginal ring, or an intrauterine device (IUD) will be&#xD;
               permitted.&#xD;
  &#xD;
           20. Unwilling to refrain from strenuous exercise (including weightlifting) 48 hours prior&#xD;
               to the admission to the clinical research unit (CRU) and 48 hours prior to any&#xD;
               outpatient visit.&#xD;
  &#xD;
           21. Significant history or clinical manifestation of any metabolic, allergic,&#xD;
               dermatological, hepatic, renal, haematological, pulmonary, cardiovascular,&#xD;
               gastrointestinal, neurological, respiratory, endocrine, ophthalmological or&#xD;
               psychiatric disorder, as determined by the PI or designee, if deemed clinically&#xD;
               relevant by PI or designee.&#xD;
  &#xD;
           22. History of stomach or intestinal surgery or resection that would potentially alter&#xD;
               absorption and/or excretion of orally administered drugs. Uncomplicated appendectomy,&#xD;
               uncomplicated cholecystectomy and hernia repair will be allowed as determined by the&#xD;
               PI or designee.&#xD;
  &#xD;
           23. Use or intent to use any medications/products/food known to alter drug absorption,&#xD;
               metabolism, or elimination processes, including strong inducers or inhibitors of&#xD;
               metabolism enzymes or transporters, including but not limited to St. John's wort,&#xD;
               grapefruit, and grapefruit juice, within 14 days prior to the first administration of&#xD;
               IP, unless deemed acceptable by the PI or designee.&#xD;
  &#xD;
           24. A participant who, in the opinion of the PI or designee, should not participate in&#xD;
               this study&#xD;
  &#xD;
           25. Anything that the PI considers would jeopardise the safety of the participant, prevent&#xD;
               complete participation in the study, or compromise interpretation of the study data.&#xD;
  &#xD;
           26. Smoked more than 5 cigarettes per week 3 months prior to Screening.&#xD;
  &#xD;
           27. Has a positive cotinine at Screening and on Day -1 and or disagreed abstinence from&#xD;
               the use of any tobacco products 2 weeks prior to admission to the CRU and throughout&#xD;
               the study period.&#xD;
  &#xD;
           28. Optic nerve disease and cataracts and those with a history of related conditions&#xD;
  &#xD;
               -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Qiuyue Qu</last_name>
      <phone>+86 021 68583863</phone>
      <email>qyqu@asieris.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zoey Zhao</last_name>
      <phone>+86 021 68583863</phone>
      <email>vzhao@asieris.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nucleus Network Pty Ltd</name>
        <address>
          <city>Melbourne</city>
          <state>Victoria</state>
          <zip>3004</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Philip Ryan, Dr</last_name>
        <phone>(03) 8593 9800</phone>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Urinary Bladder Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06034015
  org study id: YHGT-PN-02
  nct id: NCT06034015
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study
        conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER
        capsules in comparison to APL-1202 IR tablets.
  The study will have 2 parts: Each study part will comprise 2 dosing periods with a 72-hour
        washout period in between:
  
        Period 1: APL-1202 IR tablet dosing and Period 2: APL-1501 ER capsule dosing.
  
        In Part A dosing will be single day/single dosing for the APL-1202 IR tablets, and single
        day/single dosing the APL-1501 ER capsules with 24 participants in 3 sequential cohorts,
        Cohorts A1, A2, and A3. Each cohort will enrol 8 participants, with male to female
        participants in a 1:1 ratio. In Period 1/Day 1, participants in all cohorts will be dosed
        with single dose of 375 mg APL-1202 IR tablets which will followed by a washout period of at
        least 72 hours, after which participants will be dosed with single dose of APL-1501 ER
        capsules in Period 2/Day 4, .
  
        In Part B dosing will be multi-day/TID dosing for the APL-1202 IR tablets, and multi-day/BID
        dosing the APL-1501 ER capsules with 24 participants in 2 sequential cohorts, Cohorts B1 and
        B2. Each cohort will enrol 12 participants, with male to female participants in a 1:1 ratio
        and in each of the 2 study periods, participants will be administered IP for 5 days. In
        period 1, participants will administered with APL-1202 IR tablet (TID) on Day 1, Day 2, Day
        3, Day 4, and Day 5 and period 2 with APL-1501 ER capsule (BID) dosing on Day 9, Day 10, Day
        11, Day 12, and morning of Day 13.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Adverse Events (AEs)
  time frame: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
  description: Number of participants with AEs
  measure: Serious Adverse Events (SAEs)
  time frame: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
  description: Number of participants with SAEs
  measure: Treatement Emergent Adverse Events (TEAEs)
  time frame: Part A: upto Day 11 post dose follow up; Part B: Upto Day 20 post dose follow up
  description: Number of participants with TEAEs
  measure: PK parameters: area under the curve (AUC)
  time frame: up to 120 hours post dose in each treatment period
  description: Area under the curve (AUC) of APL-1501 ER capsules and APL-1202 IR Tablets
  measure: PK parameters: maximum concentration (Cmax)
  time frame: up to 120 hours post dose in each treatment period
  description: maximum concentration (Cmax), of APL-1501 ER capsules and APL-1202 IR Tablets
  measure: PK parameters: Tmax
  time frame: up to 120 hours post dose in each treatment period
  description: Tmax of APL-1501 ER capsules and APL-1202 IR Tablets
  measure: PK parameters: half-life (t1/2)
  time frame: up to 120 hours post dose in each treatment period
  description: apparent t1/2 of APL-1501 ER capsules and APL-1202 IR Tablets
  measure: Urine PK parameters: Renal clearance (CLr)
  time frame: up to 120 hours post dose in each treatment period
  description: Urine concentration of APL-1202 Tablets.
  measure: Urine PK parameters: Total amount of the APL-1202 excreted in urine from time t1 to t2 hours (Aet1-t2)
  time frame: up to 120 hours post dose in each treatment period
  description: Urine concentration of APL-1202 Tablets.
  measure: PK Parameters: Apparent total plasma clearance (CL/F)
  time frame: up to 120 hours post dose in each treatment period
  description: CL/F of APL-1501 ER capsules and APL-1202 IR Tablets
  measure: PK Parameters: Apparent terminal volume of distribution (Vz/F)
  time frame: up to 120 hours post dose in each treatment period
  description: Vz/F of APL-1501 ER capsules and APL-1202 IR Tablets
  arm group label: Part A
  arm group type: Active Comparator
  arm group label: Part B
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: APL-1202 and APL-1501 (Single ascending dose)
  description: Period 1 drug adminstration (APL-1202 IR tablet , single dose of 375mg will be administered orally on Day 1; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered as single dose on Day 4.
  arm group label: Part A
  intervention type: Drug
  intervention name: APL-1202 and APL-1501 (Multiple Ascending dose)
  description: Period 1 drug adminstration (APL-1202 IR of 375mg will be administered thrice a day (TID) orally from Day 1 to Day 5; washout period of 72 hrs; Period 2 drug administration (APL-1501 ER capsules of 764mg, 1146 mg and 1528 mg will be administered twice daily (BID) from Day 9 to 13.
  arm group label: Part B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qiuyue Qu
  phone: +86 021 68583863
  email: qyqu@asieris.cn
  last name: Zoey Zhao
  phone: +86 021 68583863
  email: vzhao@asieris.cn
  facility: 
  contact: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: No