Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.

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: NCT03388515
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Shenyang Sunshine Pharmaceutical Co., LTD.

Brief Summary:
SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.

Condition or disease Intervention/treatment Phase
Gout Biological: SSS11 Other: placebo Phase 1

Detailed Description:

Objectives:

Primary:

• To assess the safety, tolerability of single dose SSS11 in healthy subjects

Secondary:

• To assess the pharmacokinetics, pharmacodynamics and immunogenicity of SSS-11 in healthy subjects

Enrollment and Number of Arms (planned):

40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10 subjects each.

Original primary outcome Measures:

Safety: Physical exam,ECG,Clinical laboratory tests,AE,SAE Tolerance assessment:MDT,DLT

Original secondary outcome Measures:

pharmacokinetics: Cmax, Tmax, AUC, CL, Vd, t1/2 pharmacodynamics: level of serum uric acid Immunogenicity :anti-SSS11, anti-uricase and anti-PEG antibodies

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled, Single-dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SSS11 Administered Intravenously in Healthy Volunteers.
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
Experimental: SSS11, 1.5mg
SSS11, 1.5mg, iv, single dose at Day 1;
Biological: SSS11
IV infusion for 60 min.
Other Name: pegsiticase

Other: placebo
IV infusion for 60 min.

Experimental: SSS11, 3.0mg
SSS11, 3.0mg, iv, single dose at Day 1;
Biological: SSS11
IV infusion for 60 min.
Other Name: pegsiticase

Other: placebo
IV infusion for 60 min.

Experimental: SSS11, 6.0mg
SSS11, 6.0mg, iv, single dose at Day 1;
Biological: SSS11
IV infusion for 60 min.
Other Name: pegsiticase

Other: placebo
IV infusion for 60 min.

Experimental: SSS11, 12.0mg
SSS11, 12.0mg, iv, single dose at Day 1;
Biological: SSS11
IV infusion for 60 min.
Other Name: pegsiticase

Other: placebo
IV infusion for 60 min.

Experimental: SSS11, 24.0mg
SSS11, 24.0mg, iv, single dose at Day 1;
Biological: SSS11
IV infusion for 60 min.
Other Name: pegsiticase

Other: placebo
IV infusion for 60 min.




Primary Outcome Measures :
  1. incidence of adverse events [ Time Frame: baseline to 4 weeks ]
    incidence of adverse events

  2. maximum tolerable dose [ Time Frame: baseline to 4 weeks ]
    maximum tolerable dose


Secondary Outcome Measures :
  1. peak plasma concentration [ Time Frame: baseline to 4 weeks ]
    peak plasma concentration

  2. area under the plasma concentration versus time curve [ Time Frame: baseline to 4 weeks ]
    area under the plasma concentration versus time curve

  3. level of serum uric acid [ Time Frame: baseline to 4 weeks ]
    level of serum uric acid

  4. Immunogenicity [ Time Frame: baseline to 52 weeks ]
    anti-SSS11



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

1. Males and females, 18-45 years of age at time of consent; 2. Subjects are in good health, without any clinical significant symptoms or laboratory test; 3. Having a body mass index between 19 and 28 kilogram per meter square (kg/m²); 4. Capable of giving written informed consent 5. Understanding and being willing to comply with the requirements of protocol, participate to complete the study; 6. Having recovered if received a surgery before . Exclusion criteria:

  1. Allergic condition or having the history of allergic reactions to any drugs, pegylated products, or more than two substances;
  2. Use of any medicine within 4 weeks or shorter than 5 half-lives;
  3. Use of any medicine within 12 weeks, which is harm to any organ;
  4. Participated in any other clinical trial within 12 weeks;
  5. History of blood donation within 12 weeks;
  6. History of glucose-6-phosphate dehydrogenase deficiency;
  7. History of catalase deficiency;
  8. Any significant disease, including but not limited to the following: digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatry system, hematological system, immune system, metabolic system abnormity.
  9. Abnormal significance clinical laboratory tests within 2 weeks such as routine blood test and urinalysis, blood chemistry, ECG.
  10. Positive serology for hepatitis B surface antigen , or antibodies to hepatitis C, or HIV and syphilis;
  11. Pregnancy, planning pregnancy, or breastfeeding;
  12. Positive pregnancy test;
  13. Male subject without effective contraception or his partner intend to be pregnant within 6 months;
  14. History of mental disorder or disabilities legally;
  15. History of alcohol abusing during the last 6 months;
  16. More than 5 cigarettes per day during the last 6 months;
  17. Positive drug abuse or alcohol test;
  18. More than 1L of strong tea, coffee or caffeine drink per day;
  19. Can't understand the content of informed consent form ;
  20. Any condition, which investigators consider, is not fit for the trial

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): NCT03388515


Contacts
Layout table for location contacts
Contact: Quanrui Wu, Master 13601126093 wuquanrui@3sbio.com

Locations
Layout table for location information
China, Zhejiang
The First Affilicated Hospital Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Jian zhong Shen tu, Doctor    0571-87236560    stjz@zju.edu.cn   
Principal Investigator: Jian zhong Shen tu, Doctor         
Sponsors and Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
Investigators
Layout table for investigator information
Principal Investigator: Jianzhong Shentu, Doctor The First Affilicated Hospital Zhejiang University

Layout table for additonal information
Responsible Party: Shenyang Sunshine Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT03388515    
Other Study ID Numbers: SSS11
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No