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

NCT ID: NCT03388515

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2020-01-31

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.

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

Conditions

Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SSS11, 1.5mg

SSS11, 1.5mg, iv, single dose at Day 1;

Group Type: EXPERIMENTAL

SSS11

Intervention Type: BIOLOGICAL

IV infusion for 60 min.

placebo

Intervention Type: OTHER

IV infusion for 60 min.

SSS11, 3.0mg

SSS11, 3.0mg, iv, single dose at Day 1;

Group Type: EXPERIMENTAL

SSS11

Intervention Type: BIOLOGICAL

IV infusion for 60 min.

placebo

Intervention Type: OTHER

IV infusion for 60 min.

SSS11, 6.0mg

SSS11, 6.0mg, iv, single dose at Day 1;

Group Type: EXPERIMENTAL

SSS11

Intervention Type: BIOLOGICAL

IV infusion for 60 min.

placebo

Intervention Type: OTHER

IV infusion for 60 min.

SSS11, 12.0mg

SSS11, 12.0mg, iv, single dose at Day 1;

Group Type: EXPERIMENTAL

SSS11

Intervention Type: BIOLOGICAL

IV infusion for 60 min.

placebo

Intervention Type: OTHER

IV infusion for 60 min.

SSS11, 24.0mg

SSS11, 24.0mg, iv, single dose at Day 1;

Group Type: EXPERIMENTAL

SSS11

Intervention Type: BIOLOGICAL

IV infusion for 60 min.

placebo

Intervention Type: OTHER

IV infusion for 60 min.

Interventions

SSS11

IV infusion for 60 min.

Intervention Type: BIOLOGICAL

placebo

IV infusion for 60 min.

Intervention Type: OTHER

Other Intervention Names

pegsiticase

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianzhong Shentu, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affilicated Hospital Zhejiang University

Locations

The First Affilicated Hospital Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Quanrui Wu, Master

Role: CONTACT

wuquanrui@3sbio.com

13601126093

Facility Contacts

Jian zhong Shen tu, Doctor

Role: primary

stjz@zju.edu.cn

0571-87236560

Other Identifiers

SSS11

Identifier Type: -

Identifier Source: org_study_id