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

Gout Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388515
• Other study ID #: SSS11
• Status: Recruiting
• Phase: Phase 1
• Start date: October 9, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2017
• Source: Shenyang Sunshine Pharmaceutical Co., LTD.
• Contact: Quanrui Wu, Master
• Phone: 13601126093
• Email: wuquanrui[@]3sbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Biological:
• SSS11
IV infusion for 60 min.

Other:
• placebo
IV infusion for 60 min.

Locations

Country	Name	City	State
China	The First Affilicated Hospital Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Sunshine Pharmaceutical Co., LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse events	incidence of adverse events	baseline to 4 weeks
Primary	maximum tolerable dose	maximum tolerable dose	baseline to 4 weeks
Secondary	peak plasma concentration	peak plasma concentration	baseline to 4 weeks
Secondary	area under the plasma concentration versus time curve	area under the plasma concentration versus time curve	baseline to 4 weeks
Secondary	level of serum uric acid	level of serum uric acid	baseline to 4 weeks
Secondary	Immunogenicity	anti-SSS11	baseline to 52 weeks