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

NCT04047394 | Unknown Phase 1

• 1 other identifier: SYSS-SSS11-UND-Ⅰ-02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gout

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

  From beginning of drug administration to day 56

• Uric acid levels in urine

  From beginning of drug administration to day 6

Study Arms (1)

PEGylated recombinant candida urate oxidase

EXPERIMENTAL

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

Interventions

PEGylated recombinant candida urate oxidase DRUG

PEGylated recombinant candida urate oxidase is a combination of 20kDa linear polyethylene glycol (PEG) linked to Candida utilis recombinant uricase by succinimide succinate

Also known as: SSS11

PEGylated recombinant candida urate oxidase

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510799, China

RECRUITING

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Xianbo Li, MD

CONTACT

020-85959116; 285641182@qq.com

Jianzhong Shentu, PhD

CONTACT

13957111817; stjz@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: October 22, 2019
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

CN (1)