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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Quanrui Wu, Master; 13601126093; wuquanrui@3sbio.com

Locations

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

• Principal Investigator: Jianzhong Shentu, Doctor; The First Affilicated Hospital Zhejiang University

More Information

• Responsible Party: Shenyang Sunshine Pharmaceutical Co., LTD.
• ClinicalTrials.gov Identifier: NCT03388515
• Other Study ID Numbers: SSS11
• First Posted: January 3, 2018
• Last Update Posted: September 14, 2018
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No