A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers

An Open Label, Single-dose, Dose-increasing Study to Assess the Safety, Tolerability, PK and Preliminary PD of PEGylated Recombinant Candida Urate Oxidase (SSS11) for Injection in Chinese Healthy Adult Volunteers

To evaluate the safety, tolerability, PK and preliminary PD of SSS11 for injection in chinese healthy adult volunteers.

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Drug: PEGylated recombinant candida urate oxidase

Detailed Description

This is a phase I, open label, single-dose, dose-increasing study to assess the safety, tolerability and PK characteristics of healthy humans after injection of SSS11, provide a reference for subsequent clinical studies and give preliminary assessment of the immunogenicity and PD of SSS11.

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xianbo Li, MD; Phone Number: 020-85959116; Email: 285641182@qq.com
• Study Contact Backup: Name: Jianzhong Shentu, PhD; Phone Number: 13957111817; Email: stjz@zju.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510799
      • Recruiting
      • The Fifth Affiliated Hospital of Guangzhou Medical University
      • Contact: Li Xianbo, MD
      • Principal Investigator: Xianbo LI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects in the age range between 18 and 45 years old (inclusive), male or female
• In good health (no significant clinical symptoms or abnormal laboratory test results without clinical significance)
• BMI within the range between 19 and 28 kg/m2 (inclusive)
• Voluntarily sign the written informed consent
• Be able to understand and comply with the requirements of clinical protocols, expected to complete the whole trial process
• Subjects achieving full recovery if had the surgical treatment

Exclusion Criteria:

• Subjects cannot tolerate intravenous injection
• Allergies or previous history of drug allergy, or allergic history of PEG-drugs, or previous history of allergies to two or more substances
• Any abnormalities detected in three allergen tests (Special allergen screening - mixed mould, total IgE assay, special allergen screening - HX2)
• Subjects having anti- PEG antibody
• Taking any medicine before enrollment, and the regimen was less than five half-life periods or 4 weeks (Subject to the longest of the two)
• Has a history of vaccination within 12 weeks before enrollment, or intend to receive vaccines during the study
• Taking any other clinical trials within 12 weeks before enrollment,or have used similar drugs to the study drug
• Having a history of blood donation within 12 weeks before enrollment
• Having a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or abnormal G6PD detection
• Having a history of catalase deficiency or evidence that individuals meet the criteria for catalase deficiency
• Having a history of serious diseases, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system diseases and metabolic abnormalities
• Having abnormalities and clinical significances in laboratory tests (blood routine, urine routine, blood biochemistry, etc.) and electrocardiogram findings within two weeks before enrollment
• The HBsAg, anti-HIV, anti-HCV and treponema pallidum antibody were positive
• The female within lactation, pregnancy, or having birth plan within 24 weeks
• Blood pregnancy test was positive(female)
• Male subjects who did not take effective contraception or their spouse plan to be born within 24 weeks
• Disabled person in mental or law
• Subjects having a history of alcohol abuse within 24 weeks prior to screening, equal to exceed 14 unit alcohol per week (1 unit = 12 ounces or 360 mL of beer, 1.5 ounces or 45 mL of 40% alcohol, 5 ounces or 150 mL of wine)
• Smoking more than 5 cigarettes per day within 24 weeks before screening
• Those who have had halo and fainting history
• Drug abuse test or alcohol test was positive
• Drinking more than 1L of tea, coffee and/or caffeinated beverages daily
• Those who do not understand the content of informed consent and other those who do not meet the criteria for trial inclusion
• Participants who researchers believe are not suitable (such as infirmity, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEGylated recombinant candida urate oxidase; Participants will be administered with 2mg, 3mg, 4.5mg, 6mg, 8mg, 10mg once by Intravenous injection. Subjects will be followed for 56 days.	Drug: PEGylated recombinant candida urate oxidase; PEGylated recombinant candida urate oxidase is a combination of 20kDa linear polyethylene glycol (PEG) linked to Candida utilis recombinant uricase by succinimide succinate; Other Names: SSS11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Number of subjects with Adverse events (AEs)	From the day signing in informed consent form to the day 56 post-dose
DLT	Dose-LimitingToxicity of SSS11	From day 1 to day 56
Cmax	Maximum plasma concentration (Cmax) of single dose SSS11	From beginning of drug administration to day 56
Tmax	Peak plasma time [tmax] of single dose SSS11	From beginning of drug administration to day 56
AUC	Area under the plasma concentration versus time curve (AUC) of single dose SSS11	From beginning of drug administration to day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-urate oxidase antibody	The immunogenicity of SSS11 was assessed in subjects by detecting the anti-urate oxidase antibody.	From pre-dose on week 2 up to week 1, 2, 4 and 7 post-dose.
Uric acid levels in blood	This parameter was used to evaluate the PD of SSS11 in healthy humans.	From beginning of drug administration to day 56
Uric acid levels in urine	This parameter was used to evaluate the PD of SSS11 in healthy humans.	From beginning of drug administration to day 6

Collaborators and Investigators

• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Rasburicase
• Other Study ID Numbers: SYSS-SSS11-UND-Ⅰ-02

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