GoutPhase 1NCT03388515
A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.
A Phase 1 study testing SSS11 in people with Gout, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial 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. 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?
- SSS11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2017to 31 Jan 2020
- 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
- 1. Males and females, 18-45 years of age at time of consent; 2. Subjects are in good health, without any clinical significant symptoms or laboratory test; 3. Having a body mass index between 19 and 28 kilogram per meter square (kg/m²); 4. Capable of giving written informed consent 5. Understanding and being willing to comply with the requirements of protocol, participate to complete the study; 6. Having recovered if received a surgery before . Exclusion criteria：
- 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;
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- 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;
- More than 5 cigarettes per day during the last 6 months;
- Positive drug abuse or alcohol test;
- More than 1L of strong tea, coffee or caffeine drink per day;
- Can't understand the content of informed consent form ;
- Any condition, which investigators consider, is not fit for the trial
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affilicated Hospital Zhejiang University
Hangzhou, Zhejiang
Jian zhong Shen tu, Doctor, 0571-87236560, stjz@zju.edu.cn
Jian zhong Shen tu, Doctor
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Single-dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SSS11 Administered Intravenously in Healthy Volunteers.
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.
Read the detailed description
Objectives:
Primary:
- To assess the safety, tolerability of single dose SSS11 in healthy subjects
Secondary:
- To assess the pharmacokinetics, pharmacodynamics and immunogenicity of SSS-11 in healthy subjects
Enrollment and Number of Arms (planned):
40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10 subjects each.
Original primary outcome Measures:
Safety: Physical exam，ECG，Clinical laboratory tests，AE，SAE Tolerance assessment：MDT，DLT
Original secondary outcome Measures:
pharmacokinetics: Cmax, Tmax, AUC, CL, Vd, t1/2 pharmacodynamics: level of serum uric acid Immunogenicity ：anti-SSS11, anti-uricase and anti-PEG antibodies
- Conditions
- Gout
- Being tested
- SSS11, placebo
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS11Biological
Also called pegsiticase
IV infusion for 60 min.
placeboOther
IV infusion for 60 min.
| Study group | Role | What they receive |
|---|---|---|
| SSS11, 1.5mg | Experimental | SSS11, 1.5mg, iv, single dose at Day 1; Receives: Biological: SSS11; Other: placebo |
| SSS11, 3.0mg | Experimental | SSS11, 3.0mg, iv, single dose at Day 1; Receives: Biological: SSS11; Other: placebo |
| SSS11, 6.0mg | Experimental | SSS11, 6.0mg, iv, single dose at Day 1; Receives: Biological: SSS11; Other: placebo |
| SSS11, 12.0mg | Experimental | SSS11, 12.0mg, iv, single dose at Day 1; Receives: Biological: SSS11; Other: placebo |
| SSS11, 24.0mg | Experimental | SSS11, 24.0mg, iv, single dose at Day 1; Receives: Biological: SSS11; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events
incidence of adverse events
Measured: baseline to 4 weeks
maximum tolerable dose
maximum tolerable dose
Measured: baseline to 4 weeks
Secondary outcomes (4)
peak plasma concentration
peak plasma concentration
Measured: baseline to 4 weeks
area under the plasma concentration versus time curve
area under the plasma concentration versus time curve
Measured: baseline to 4 weeks
level of serum uric acid
level of serum uric acid
Measured: baseline to 4 weeks
Immunogenicity
anti-SSS11
Measured: baseline to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start9 Oct 2017
- Primary completion30 Jul 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Shentu, Doctor, Principal investigator, The First Affilicated Hospital Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388515
- Sponsor's protocol ID
- SSS11
- Status last verified
- Sep 2017
- First submitted
- 5 Dec 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Single-dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SSS11 Administered Intravenously in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03388515
- Acronym / sponsor ID
- SSS11
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
Primary:
- To assess the safety, tolerability of single dose SSS11 in healthy subjects
Secondary:
- To assess the pharmacokinetics, pharmacodynamics and immunogenicity of SSS-11 in healthy subjects
Enrollment and Number of Arms (planned):
40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10 subjects each.
Original primary outcome Measures:
Safety: Physical exam，ECG，Clinical laboratory tests，AE，SAE Tolerance assessment：MDT，DLT
Original secondary outcome Measures:
pharmacokinetics: Cmax, Tmax, AUC, CL, Vd, t1/2 pharmacodynamics: level of serum uric acid Immunogenicity ：anti-SSS11, anti-uricase and anti-PEG antibodies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SSS11, 1.5mg | Experimental | Biological: SSS11, Other: placeboSSS11, 1.5mg, iv, single dose at Day 1; |
| SSS11, 3.0mg | Experimental | Biological: SSS11, Other: placeboSSS11, 3.0mg, iv, single dose at Day 1; |
| SSS11, 6.0mg | Experimental | Biological: SSS11, Other: placeboSSS11, 6.0mg, iv, single dose at Day 1; |
| SSS11, 12.0mg | Experimental | Biological: SSS11, Other: placeboSSS11, 12.0mg, iv, single dose at Day 1; |
| SSS11, 24.0mg | Experimental | Biological: SSS11, Other: placeboSSS11, 24.0mg, iv, single dose at Day 1; |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 1. Males and females, 18-45 years of age at time of consent; 2. Subjects are in good health, without any clinical significant symptoms or laboratory test; 3. Having a body mass index between 19 and 28 kilogram per meter square (kg/m²); 4. Capable of giving written informed consent 5. Understanding and being willing to comply with the requirements of protocol, participate to complete the study; 6. Having recovered if received a surgery before . Exclusion criteria：
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSS11Also: pegsiticaseIV infusion for 60 min. | Biological | SSS11, 1.5mg, SSS11, 12.0mg, SSS11, 24.0mg, SSS11, 3.0mg, SSS11, 6.0mg |
| placeboIV infusion for 60 min. | Other | SSS11, 1.5mg, SSS11, 12.0mg, SSS11, 24.0mg, SSS11, 3.0mg, SSS11, 6.0mg |
Primary outcome
incidence of adverse events
Time frame: baseline to 4 weeks
incidence of adverse events
maximum tolerable dose
Time frame: baseline to 4 weeks
maximum tolerable dose
4 secondary outcomes
peak plasma concentration
Time frame: baseline to 4 weeks
area under the plasma concentration versus time curve
Time frame: baseline to 4 weeks
level of serum uric acid
Time frame: baseline to 4 weeks
Immunogenicity
Time frame: baseline to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianzhong Shentu, Doctor principal investigator
The First Affilicated Hospital Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSS11 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 21 inclusion and 0 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 14 Sep 2018. 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 Quanrui Wu, Master (13601126093, wuquanrui@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse events (time frame: baseline to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2018.