NCT03388515

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

December 5, 2017

Last Update Submit

September 12, 2018

Conditions

Gout

Outcome Measures

Primary Outcomes (2)

  • incidence of adverse events

    incidence of adverse events

    baseline to 4 weeks

  • maximum tolerable dose

    maximum tolerable dose

    baseline to 4 weeks

Secondary Outcomes (4)

  • peak plasma concentration

    baseline to 4 weeks

  • area under the plasma concentration versus time curve

    baseline to 4 weeks

  • level of serum uric acid

    baseline to 4 weeks

  • Immunogenicity

    baseline to 52 weeks

Study Arms (5)

SSS11, 1.5mg

EXPERIMENTAL

SSS11, 1.5mg, iv, single dose at Day 1;

Biological: SSS11Other: placebo

SSS11, 3.0mg

EXPERIMENTAL

SSS11, 3.0mg, iv, single dose at Day 1;

Biological: SSS11Other: placebo

SSS11, 6.0mg

EXPERIMENTAL

SSS11, 6.0mg, iv, single dose at Day 1;

Biological: SSS11Other: placebo

SSS11, 12.0mg

EXPERIMENTAL

SSS11, 12.0mg, iv, single dose at Day 1;

Biological: SSS11Other: placebo

SSS11, 24.0mg

EXPERIMENTAL

SSS11, 24.0mg, iv, single dose at Day 1;

Biological: SSS11Other: placebo

Interventions

SSS11BIOLOGICAL

IV infusion for 60 min.

Also known as: pegsiticase
SSS11, 1.5mgSSS11, 12.0mgSSS11, 24.0mgSSS11, 3.0mgSSS11, 6.0mg
placeboOTHER

IV infusion for 60 min.

SSS11, 1.5mgSSS11, 12.0mgSSS11, 24.0mgSSS11, 3.0mgSSS11, 6.0mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Allergic condition or having the history of allergic reactions to any drugs, pegylated products, or more than two substances;
  • Use of any medicine within 4 weeks or shorter than 5 half-lives;
  • Use of any medicine within 12 weeks, which is harm to any organ;
  • Participated in any other clinical trial within 12 weeks;
  • History of blood donation within 12 weeks;
  • History of glucose-6-phosphate dehydrogenase deficiency;
  • History of catalase deficiency;
  • 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.
  • Abnormal significance clinical laboratory tests within 2 weeks such as routine blood test and urinalysis, blood chemistry, ECG.
  • Positive serology for hepatitis B surface antigen , or antibodies to hepatitis C, or HIV and syphilis;
  • Pregnancy, planning pregnancy, or breastfeeding;
  • Positive pregnancy test;
  • Male subject without effective contraception or his partner intend to be pregnant within 6 months;
  • History of mental disorder or disabilities legally;
  • History of alcohol abusing during the last 6 months;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affilicated Hospital Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jianzhong Shentu, Doctor

    The First Affilicated Hospital Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanrui Wu, Master

CONTACT

13601126093wuquanrui@3sbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

January 3, 2018

Study Start

October 9, 2017

Primary Completion

July 30, 2019

Study Completion

January 31, 2020

Last Updated

September 14, 2018

Record last verified: 2017-09

Locations

CN(1)