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A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047394
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Shenyang Sunshine Pharmaceutical Co., LTD.

Brief Summary:
To evaluate the safety, tolerability, PK and preliminary PD of SSS11 for injection in chinese healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Gout Drug: PEGylated recombinant candida urate oxidase Phase 1

Detailed Description:
This is a phase I, open label, single-dose, dose-increasing study to assess the safety, tolerability and PK characteristics of healthy humans after injection of SSS11, provide a reference for subsequent clinical studies and give preliminary assessment of the immunogenicity and PD of SSS11.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single-dose, Dose-increasing Study to Assess the Safety, Tolerability, PK and Preliminary PD of PEGylated Recombinant Candida Urate Oxidase (SSS11) for Injection in Chinese Healthy Adult Volunteers
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
Experimental: PEGylated recombinant candida urate oxidase

There are two parts (part A and part B), part A has five dose increasing groups, part B has three dose extension groups.

Part A: Group1:2mg, Group2:3mg, Group3:6mg, Group4:9mg, Group5: 12mg. Part B: Group1:3mg, Group2:6mg, Group3:9mg.

Drug: PEGylated recombinant candida urate oxidase
PEGylated recombinant candida urate oxidase is a combination of 20kDa linear polyethylene glycol (PEG) linked to Candida utilis recombinant uricase by succinimide succinate
Other Name: SSS11




Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: From the day signing in informed consent form to the day 56 post-dose ]
    Number of subjects with Adverse events (AEs)

  2. DLT [ Time Frame: From day 1 to day 56 ]
    Dose-LimitingToxicity of SSS11

  3. Cmax [ Time Frame: From beginning of drug administration to day 56 ]
    Maximum plasma concentration (Cmax) of single dose SSS11

  4. Tmax [ Time Frame: From beginning of drug administration to day 56 ]
    Peak plasma time [tmax] of single dose SSS11

  5. AUC [ Time Frame: From beginning of drug administration to day 56 ]
    Area under the plasma concentration versus time curve (AUC) of single dose SSS11


Secondary Outcome Measures :
  1. Anti-urate oxidase antibody [ Time Frame: From pre-dose on week 2 up to week 1, 2, 4 and 7 post-dose. ]
    The immunogenicity of SSS11 was assessed in subjects by detecting the anti-urate oxidase antibody.

  2. Uric acid levels in blood [ Time Frame: From beginning of drug administration to day 56 ]
    This parameter was used to evaluate the PD of SSS11 in healthy humans.

  3. Uric acid levels in urine [ Time Frame: From beginning of drug administration to day 6 ]
    This parameter was used to evaluate the PD of SSS11 in healthy humans.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects in the age range between 18 and 45 years old (inclusive), male or female
  • In good health (no significant clinical symptoms or abnormal laboratory test results without clinical significance)
  • BMI within the range between 19 and 28 kg/m2 (inclusive)
  • Voluntarily sign the written informed consent
  • Be able to understand and comply with the requirements of clinical protocols, expected to complete the whole trial process
  • Subjects achieving full recovery if had the surgical treatment

Exclusion Criteria:

  • Subjects cannot tolerate intravenous injection
  • Allergies or previous history of drug allergy, or allergic history of PEG-drugs, or previous history of allergies to two or more substances
  • Any abnormalities detected in three allergen tests (Special allergen screening - mixed mould, total IgE assay, special allergen screening - HX2)
  • Subjects having anti- PEG antibody
  • Taking any medicine before enrollment, and the regimen was less than five half-life periods or 4 weeks (Subject to the longest of the two)
  • Taking any medicine known to have significant damage to an organ within 12 weeks before enrollment
  • Taking any other clinical trials within 12 weeks before enrollment
  • Having a history of blood donation within 12 weeks before enrollment
  • Having a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or abnormal G6PD detection
  • Having a history of catalase deficiency or evidence that individuals meet the criteria for catalase deficiency
  • Having a history of serious diseases, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system diseases and metabolic abnormalities
  • Having abnormalities and clinical significances in laboratory tests (blood routine, urine routine, blood biochemistry, etc.) and electrocardiogram findings within two weeks before enrollment
  • The HBsAg, anti-HIV, anti-HCV and treponema pallidum antibody were positive
  • The female within lactation, pregnancy, or having birth plan within 24 weeks
  • Blood pregnancy test was positive(female)
  • Male subjects who did not take effective contraception or their spouse plan to be born within 24 weeks
  • Disabled person in mental or law
  • Subjects having a history of alcohol abuse within 24 weeks prior to screening, equal to exceed 14 unit alcohol per week (1 unit = 12 ounces or 360 mL of beer, 1.5 ounces or 45 mL of 40% alcohol, 5 ounces or 150 mL of wine)
  • Smoking more than 5 cigarettes per day within 24 weeks before screening
  • Those who have had halo and fainting history
  • Drug abuse test or alcohol test was positive
  • Drinking more than 1L of tea, coffee and/or caffeinated beverages daily
  • Those who do not understand the content of informed consent and other those who do not meet the criteria for trial inclusion
  • Participants who researchers believe are not suitable (such as infirmity, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047394


Contacts
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Contact: Xianbo Li, MD 020-85959116 285641182@qq.com

Locations
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China, Guangdong
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510799
Contact: Li Xianbo, MD         
Principal Investigator: Xianbo LI, MD         
Sponsors and Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.

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Responsible Party: Shenyang Sunshine Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT04047394    
Other Study ID Numbers: SYSS-SSS11-UND-Ⅰ-02
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rasburicase
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Gout Suppressants
Antirheumatic Agents