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GoutPhase 1NCT04047394

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

A Phase 1 study testing PEGylated recombinant candida urate oxidase in people with Gout, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Gout
What is being tested?
PEGylated recombinant candida urate oxidase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
22 Oct 2019to 30 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country.

Xianbo Li, MD contact

020-85959116

285641182@qq.com

Jianzhong Shentu, PhD contact

13957111817

stjz@zju.edu.cn

China1 site, 1 recruiting

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510799

    Li Xianbo, MD

    Xianbo LI, MD

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Conditions
Gout
Being tested
PEGylated recombinant candida urate oxidase
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEGylated recombinant candida urate oxidaseDrug

    Also called SSS11

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

Study groups in NCT04047394
Study groupRoleWhat they receive
PEGylated recombinant candida urate oxidaseExperimentalParticipants will be administered with 2mg, 3mg, 4.5mg, 6mg, 8mg, 10mg once by Intravenous injection. Subjects will be followed for 56 days.
Receives: Drug: PEGylated recombinant candida urate oxidase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    Number of subjects with Adverse events (AEs)

    Measured: From the day signing in informed consent form to the day 56 post-dose

  2. DLT

    Dose-LimitingToxicity of SSS11

    Measured: From day 1 to day 56

  3. Cmax

    Maximum plasma concentration (Cmax) of single dose SSS11

    Measured: From beginning of drug administration to day 56

  4. Tmax

    Peak plasma time [tmax] of single dose SSS11

    Measured: From beginning of drug administration to day 56

  5. AUC

    Area under the plasma concentration versus time curve (AUC) of single dose SSS11

    Measured: From beginning of drug administration to day 56

Secondary outcomes (3)

  1. Anti-urate oxidase antibody

    The immunogenicity of SSS11 was assessed in subjects by detecting the anti-urate oxidase antibody.

    Measured: From pre-dose on week 2 up to week 1, 2, 4 and 7 post-dose.

  2. Uric acid levels in blood

    This parameter was used to evaluate the PD of SSS11 in healthy humans.

    Measured: From beginning of drug administration to day 56

  3. Uric acid levels in urine

    This parameter was used to evaluate the PD of SSS11 in healthy humans.

    Measured: From beginning of drug administration to day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start22 Oct 2019
  3. Primary completion30 Oct 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04047394
Sponsor's protocol ID
SYSS-SSS11-UND-Ⅰ-02
Status last verified
Jul 2021
First submitted
2 Aug 2019
Last updated
8 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PEGylated recombinant candida urate oxidase in people with Gout, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xianbo Li, MD (020-85959116, 285641182@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: From the day signing in informed consent form to the day 56 post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04047394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.

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