GoutPhase 1NCT02648269
Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels
A Phase 1 study testing SEL-110, SEL-212 and SEL-037 in people with Gout, run by Selecta Biosciences, Inc. at 6 sites in United States.
Trial summary
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Gout
- What is being tested?
- SEL-110, SEL-212 and SEL-037
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2015to Dec 2016
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ages 21 to 70 inclusive. Female subjects must be of non-childbearing potential;
- Has at the screening visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;
- The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the screening visit;
- Has adequate venous access and able to receive IV therapy;
- Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;
Who cannot join
- Prior exposure to any experimental or marketed uricase (for arms receiving SEL-037 or SEL-212);
- History of any allergy to pegylated products;
- Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;
- History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
- Presently taking a drug classified as CYP3A4 inducer or inhibitor;
- Has participated in a clinical trial within 30 days of the Screening;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
SNBL Clinical Pharmacology Center Inc.
Baltimore, Maryland, 21201
Altoona Center for Clincal Research
Duncansville, Pennsylvania, 16635
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Miami Research Associates
Miami, Florida, 33143
Davita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center, Inc.
Orlando, Florida, 32809
About this study
Official title: A Phase I Single Ascending Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 in Subjects With Elevated Blood Uric Acid
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming.
Read the detailed description
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. Cohorts of subjects in the SEL-110 only arms of the study will be given a single, ascending intravenous dose of SEL-110 and then monitored for safety and rapamycin levels (pharmacokinetics) over 30 days. Cohorts of subjects in the SEL-212 arms of the study will be given a single, ascending intravenous dose of SEL-110 with a fixed dose of SEL-037 and then monitored for safety, rapamycin levels, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days. One additional control group with receive a single intravenous infusion of SEL-037 at a fixed dose and then monitored for safety, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days
- Conditions
- Gout
- Being tested
- SEL-110, SEL-212, SEL-037
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEL-110Drug
SEL-212Biological
SEL-037Biological
| Study group | Role | What they receive |
|---|---|---|
| SEL-110 | Experimental | Single intravenous dose of SEL-110 Receives: Drug: SEL-110; Biological: SEL-212 |
| SEL-212 | Experimental | Single intravenous dose of SEL-110 plus SEL-037 (pegsiticase) Receives: Biological: SEL-212 |
| SEL-037 | Experimental | Single intravenous dose of SEL-037 (pegsiticase) Receives: Biological: SEL-037 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
To assess the safety and tolerability of a single infusion of SEL-110, SEL-212 or SEL-037 as assessed by frequency of drug related adverse events, graded by severity
Measured: 30 days
Secondary outcomes (4)
Pharmacokinetics of SEL-110 (AUC)
Measurement of the pharmacokinetics of SEL-110 over 30 days by area under the blood concentration versus time curve (AUC)
Measured: 30 days
Pharmacokinetics of SEL-037 (AUC)
Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)
Measured: 30 days
Pharmacodynamics of SEL-037 (blood uric acid levels)
Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days
Measured: 30 days
Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)
Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selecta Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648269
- Sponsor's protocol ID
- SEL-212/101
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sands E, Kivitz A, DeHaan W, Leung SS, Johnston L, Kishimoto TK. Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia. Nat Commun. 2022 Jan 12;13(1):272. doi: 10.1038/s41467-021-27945-7.
PubMed 35022448
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Ascending Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 in Subjects With Elevated Blood Uric Acid
- ClinicalTrials.gov ID
- NCT02648269
- Acronym / sponsor ID
- SEL-212/101
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Selecta Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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.
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming.
Detailed description
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. Cohorts of subjects in the SEL-110 only arms of the study will be given a single, ascending intravenous dose of SEL-110 and then monitored for safety and rapamycin levels (pharmacokinetics) over 30 days. Cohorts of subjects in the SEL-212 arms of the study will be given a single, ascending intravenous dose of SEL-110 with a fixed dose of SEL-037 and then monitored for safety, rapamycin levels, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days. One additional control group with receive a single intravenous infusion of SEL-037 at a fixed dose and then monitored for safety, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEL-110 | Experimental | Drug: SEL-110, Biological: SEL-212Single intravenous dose of SEL-110 |
| SEL-212 | Experimental | Biological: SEL-212Single intravenous dose of SEL-110 plus SEL-037 (pegsiticase) |
| SEL-037 | Experimental | Biological: SEL-037Single intravenous dose of SEL-037 (pegsiticase) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects ages 21 to 70 inclusive. Female subjects must be of non-childbearing potential;
- Has at the screening visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;
- The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the screening visit;
- Has adequate venous access and able to receive IV therapy;
- Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;
Key exclusion criteria (6 listed)
- Prior exposure to any experimental or marketed uricase (for arms receiving SEL-037 or SEL-212);
- History of any allergy to pegylated products;
- Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;
- History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
- Presently taking a drug classified as CYP3A4 inducer or inhibitor;
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 |
|---|---|---|
| SEL-110 | Drug | SEL-110 |
| SEL-212 | Biological | SEL-110, SEL-212 |
| SEL-037 | Biological | SEL-037 |
Primary outcome
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
Time frame: 30 days
To assess the safety and tolerability of a single infusion of SEL-110, SEL-212 or SEL-037 as assessed by frequency of drug related adverse events, graded by severity
4 secondary outcomes
Pharmacokinetics of SEL-110 (AUC)
Time frame: 30 days
Pharmacokinetics of SEL-037 (AUC)
Time frame: 30 days
Pharmacodynamics of SEL-037 (blood uric acid levels)
Time frame: 30 days
Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 35022448Sands E, Kivitz A, DeHaan W, Leung SS, Johnston L, Kishimoto TK. Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia. Nat Commun. 2022 Jan 12;13(1):272. doi: 10.1038/s41467-021-27945-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SEL-110, SEL-212 and SEL-037 in people with Gout, run by Selecta Biosciences, Inc. at 6 sites in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity (time frame: 30 days). 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 NCT02648269, which also lists 1 linked publication.
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 30 Jan 2017.