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

Shenyang Sunshine Pharmaceutical

Status and phase

Unknown

Phase 1

Conditions

Gout

Treatments

Drug: PEGylated recombinant candida urate oxidase

Study type

Interventional

Funder types

Industry

Identifiers

NCT04047394

SYSS-SSS11-UND-Ⅰ-02

Details and patient eligibility

About

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

Full 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.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.)