Status:
UNKNOWN
A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Conditions:
Gout
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 pharmacodynam...
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 hea...
Eligibility Criteria
Inclusion
- 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：
- Allergic condition or having the history of allergic reactions to any drugs, pegylated products, or more than two substances;
- Use of any medicine within 4 weeks or shorter than 5 half-lives;
- Use of any medicine within 12 weeks, which is harm to any organ;
- Participated in any other clinical trial within 12 weeks;
- History of blood donation within 12 weeks;
- History of glucose-6-phosphate dehydrogenase deficiency;
- History of catalase deficiency;
- 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.
- Abnormal significance clinical laboratory tests within 2 weeks such as routine blood test and urinalysis, blood chemistry, ECG.
- Positive serology for hepatitis B surface antigen , or antibodies to hepatitis C, or HIV and syphilis;
- Pregnancy, planning pregnancy, or breastfeeding;
- Positive pregnancy test;
- Male subject without effective contraception or his partner intend to be pregnant within 6 months;
- History of mental disorder or disabilities legally;
- History of alcohol abusing during the last 6 months;
- More than 5 cigarettes per day during the last 6 months;
- Positive drug abuse or alcohol test;
- More than 1L of strong tea, coffee or caffeine drink per day;
- Can't understand the content of informed consent form ;
- Any condition, which investigators consider, is not fit for the trial
Exclusion
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03388515
Start Date
October 9 2017
End Date
January 31 2020
Last Update
September 14 2018
Active Locations (1)
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1
The First Affilicated Hospital Zhejiang University
Hangzhou, Zhejiang, China