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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047394
• Other study ID #: SYSS-SSS11-UND-?-02
• Status: Recruiting
• Phase: Phase 1
• Start date: October 22, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2021
• Source: Shenyang Sunshine Pharmaceutical Co., LTD.
• Contact: Xianbo Li, MD
• Phone: 020-85959116
• Email: 285641182[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Gout

Intervention

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

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Sunshine Pharmaceutical Co., LTD.

Country where clinical trial is conducted

China, 

Outcome

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