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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Gout
• Intervention / Treatment: Biological: SSS11; Other: placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affilicated Hospital Zhejiang University
      • Contact: Jian zhong Shen tu, Doctor; Phone Number: 0571-87236560; Email: stjz@zju.edu.cn
      • Principal Investigator: Jian zhong Shen tu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SSS11, 1.5mg; SSS11, 1.5mg, iv, single dose at Day 1;	Biological: SSS11; IV infusion for 60 min.; Other Names: 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 Names: 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 Names: 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 Names: 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 Names: pegsiticase; Other: placebo; IV infusion for 60 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse events	incidence of adverse events	baseline to 4 weeks
maximum tolerable dose	maximum tolerable dose	baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak plasma concentration	peak plasma concentration	baseline to 4 weeks
area under the plasma concentration versus time curve	area under the plasma concentration versus time curve	baseline to 4 weeks
level of serum uric acid	level of serum uric acid	baseline to 4 weeks
Immunogenicity	anti-SSS11	baseline to 52 weeks

Collaborators and Investigators

• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
• Investigators: Principal Investigator: Jianzhong Shentu, Doctor, The First Affilicated Hospital Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2017
• Primary Completion (ANTICIPATED): July 30, 2019
• Study Completion (ANTICIPATED): January 31, 2020

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 24, 2017
• First Posted (ACTUAL): January 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SSS11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No