GoutPhase 1NCT06678581
SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects
A Phase 1 study testing SAP-001 in people with Gout and Hyperuricemia, run by Shanton Pharma Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia. To evaluate the safety and tolerability of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- SAP-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2023to 11 Jan 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female Chinese subjects between the ages of 18 and 55 years (inclusive of the cutoff value, the time of signing the informed consent shall prevail) in good health (as determined by medical history, physical examination, 12-lead ECG [heart rate > 50 bpm, PR interval < 200 ms, and QRS width < 120 ms], vital sign measurements, and normal or no clinically significant abnormalities in clinical laboratory evaluations as assessed by the investigator (or designee) at screening and Day -1);
- Body mass index between 18 and 28 kg/m2 (including the cutoff value) at screening, not less than 50 kg for men and 45 kg for women;
- Serum uric acid (sUA) level ≤ 420 μmol/L (7 mg/dL) during the screening period and no history of gout;
- Males and females of childbearing potential must agree to use at least one medically acceptable form of contraception (see Appendix for specific contraceptive measures) from screening through 3 months after the last dose;
- The subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form;
- Able to complete trial per protocol requirements.
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- Male or female Chinese subjects between 18 and 65 years of age, inclusive of the cutoff values, the time of signing the informed consent shall prevail;
- Body mass index between 19 and 32 kg/m2 (including cutoff values) at screening;
- Serum uric acid (sUA) ≥ 420 μmol/L (7.0 mg/dL) at screening or baseline (D-1);
- Patients met 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for gout at screening and without risk of acute gout attack;
- Subjects do not use any uric acid-lowering drugs within 2 weeks prior to dosing;
- Males and females of childbearing potential must agree to use at least one medically acceptable form of contraception (see Appendix for specific contraceptive measures) from screening through 3 months after the last dose;
- The subject fully understands the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form;
- Able to complete trial per protocol requirements.
Who cannot join
- Clinically abnormal diseases or factors, including but not limited to neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal system diseases or other factors, which investigator considered inappropriate for study participation;
- Subjects with a history of gastrointestinal surgery or resection (subjects who have undergone appendectomy and/or herniorrhaphy may be included in the study);
- Clinically significant liver function test abnormalities define as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times of the upper limit of normal (ULN) or total bilirubin (TBIL) > ULN at screening or baseline (D-1); or history of clinically significant acute or chronic hepatitis (including infectious, metabolic, autoimmune, hereditary, ischemic, or other forms), liver cirrhosis, or liver tumor.
- Significant cardiovascular diseases, including:
- Acute decompensated heart failure, including exacerbation of chronic heart failure, manifests as signs and symptoms requiring hospitalization and/or intravenous diuretic therapy [New York Heart Association (NYHA) class III to IV], or hemodynamically significant valvular disease and/or other vascular obstructive lesions within 3 months prior to the screening visit;
- Any of the following within 6 months prior to the screening visit:
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- Significant cardiac, cerebral, and/or carotid artery diseases, including but not limited to acute coronary syndrome, myocardial infarction, stroke, and/or transient ischemic attack, or unsatisfactory recovery or unstable control at screening;
- Major cardiovascular or percutaneous procedures, including cardiac ablation, coronary revascularization, and carotid angioplasty; cardiovascular disease likely to require surgical or percutaneous intervention during participation in the study or within 6 months of the screening visit;
- History of clinically significant cardiac arrhythmia, including but not limited to any of the following:
- Symptomatic bradycardia and/or symptomatic ventricular arrhythmia within 3 months prior to the screening visit;
- Second- or third-degree atrioventricular block, sick sinus syndrome, left bundle branch block;
- QTcF > 450 ms for males and > 470 ms for females prior to screening or randomization;
- History of QT prolongation, long QT syndrome, or torsade de pointes;
- Subjects with a history of malignancy (excluding basal cell carcinoma) within 5 years before screening;
- History of acute infection within 14 days prior to screening;
- History of prescription drug abuse or illicit drug use within 6 months before screening, or drug abuse screening positive at baseline (D-1);
- Consumption of more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 6 months before screening or consumption of alcoholic products 48 hours before dosing, or positive baseline (D-1) alcohol breath test; participation in strenuous exercise 48 hours before dosing;
- Any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines that affect blood uric acid levels within 14 days prior to the first dose;
- Moderate to severe smoker (more than 10 cigarettes per day) within 6 months prior to screening;
- Subjects who have a history of special diet (eg, coffee and other caffeine-containing and alcoholic beverages, tea, grapefruit, etc.) within 14 days before screening;
- Subjects who become diarrhea for drinking milk are excluded from the food effect group.
- Human immunodeficiency virus (HIV) antibody positive or syphilis (TP) antibody positive;
- Women who have positive blood pregnancy (β-HCG) test at screening period or baseline (D-1) or are lactating or plan to have children from before the first dose to 3 months after the end of the trial;
- Receiving any other study drug within 3 months prior to the first dose of study drug, or planning to use the study drug during the study;
- History of blood donation or blood loss of more than 400 mL within 30 days prior to screening;
- Any other conditions that, in the opinion of the investigator, might affect the subject's ability to give informed consent or to follow the protocol, or that the subject's participation in the trial might affect the trial's results or his/her own safety.
- For MAD study
- Clinically abnormal diseases or factors, including but not limited to neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal system diseases or other factors, which investigator considered inappropriate for study participation;
- Patients with a history of gastrointestinal surgery or resection (subjects who have undergone appendectomy and/or herniorrhaphy may be included in the study);
- Clinically significant liver function test abnormalities define as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times of the upper limit of normal (ULN) or total bilirubin (TBIL) > ULN at screening or baseline (D-1); or history of clinically significant acute or chronic hepatitis (including infectious, metabolic, autoimmune, hereditary, ischemic, or other forms), liver cirrhosis, or liver tumor.
- sCr > 132.6 μmol/L (1.5 mg/dL) and/or eGFR ≤ 60 mL/min/1.73 m2 (calculated by CKD-EPI formula) at screening;
- Significant cardiovascular diseases, including:
- Acute decompensated heart failure, including exacerbation of chronic heart failure, manifests as signs and symptoms requiring hospitalization and/or intravenous diuretic therapy [New York Heart Association (NYHA) class III to IV], or hemodynamically significant valvular disease and/or other vascular obstructive lesions within 3 months prior to the screening visit;
- Any of the following within 6 months prior to the screening visit:
- Significant cardiac, cerebral, and/or carotid artery diseases, including but not limited to acute coronary syndrome, myocardial infarction, stroke, and/or transient ischemic attack, or unsatisfactory recovery or unstable control at screening;
- Major cardiovascular or percutaneous procedures, including cardiac ablation, coronary revascularization, and carotid angioplasty; cardiovascular disease likely to require surgical or percutaneous intervention during participation in the study or within 6 months of the screening visit;
- History of clinically significant cardiac arrhythmia, including but not limited to any of the following:
- Symptomatic bradycardia and/or symptomatic ventricular arrhythmia within 3 months prior to the screening visit;
- Second- or third-degree atrioventricular block, sick sinus syndrome, left bundle branch block;
- New or untreated atrial fibrillation [Subjects with atrial fibrillation with stable (at least 6 months) asymptomatic heart rate control on appropriate therapy (which may include anticoagulation) are allowed to enroll in this study];
- QTcF > 450 ms for males and > 470 ms for females prior to screening or randomization;
- History of QT prolongation, long QT syndrome, or torsade de pointes;
- History of cardiac transplantation, or subject on cardiac transplant checklist or use of left ventricular assist device;
- History of prescription drug abuse or illicit drug use within 6 months before screening, or drug abuse screening positive at baseline (D-1);
- Consumption of more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 6 months before screening or consumption of alcoholic products 48 hours before dosing, or positive baseline (D-1) alcohol breath test;
- Any prescription drug, over-the-counter drug, any vitamin product, or herbal medicine that had an effect on serum uric acid level within 14 days prior to the first dose; exceptions can be discussed on a case-by-case basis (e.g., long-term stable use of low dose aspirin) after discussion and agreement between the investigator and the Sponsor;
- Participates in strenuous exercise 48 hours before administration;
- Human immunodeficiency virus (HIV) antibody positive or syphilis (TP) antibody positive;
- Women who have positive pregnancy test or are lactating during the screening period or baseline (D-1) or plan to have children from before the first dose to 3 months after the end of the trial;
- Patients who have received any other investigational drugs within 3 months prior to the first dose of study drug or plan to use investigational drugs during the study;
- History of blood donation or blood loss of more than 400 mL within 30 days prior to screening;
- Patients with a history of malignancy (excluding basal cell carcinoma) within 5 years before screening;
- History of acute infection within 14 days prior to screening;
- Any other conditions that, in the opinion of the investigator, might affect the subject's ability to give informed consent or to follow the protocol, or that the subject's participation in the trial might affect the trial's results or his/her own safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single or Multiple Dose Escalation Study to Evaluate the Safety, PK Profile, PD Profile and Food Effects of SAP-001 Tablets in Healthy Chinese Subjects and Gout Patients With Hyperuricemia
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia.
To evaluate the safety and tolerability of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacodynamics (PD) profile of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia.
To evaluate the pharmacokinetics profile of SAP-001 tablets in healthy Chinese subjects under fasted/fed conditions.
- Conditions
- Gout, Hyperuricemia
- Being tested
- SAP-001, Placebo
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAP-001Drug
Also called SAP-001 tablet
Solid Oral Tablet
PlaceboDrug
Also called placebo tablet
Solid Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| SAP-001 | Experimental | Four sequentially ascending dose cohorts are set in SAD study. Three sequentially ascending dose cohorts are set in MAD study. Receives: Drug: SAP-001 |
| Placebo | Experimental | placebo tablets for oral Receives: Drug: Placebo |
| A Randomized, Open-label, two-period crossover FE study | Experimental | 12 subjects are randomized in a 1:1 ratio to sequences A (fasting - fed) and B (fed - fasting). Receives: Drug: SAP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentration (Cmax)
PK parameters
Measured: 168 hours
area under the drug concentration-time curve from time 0 to the last measurable concentration sample collection time t (AUC0-t)
PK parameters
Measured: 168 hours
area under the drug concentration-time curve from time 0 to 168 hours (AUC0-168h)
PK parameters
Measured: 168 hours
time to maximum concentration (Tmax)
PK parameters
Measured: 168 hours
elimination half-life (t1/2)
PK parameters
Measured: 168 hours
cumulative urinary excretion from 0 to 168 h (Ae0-168h)
PK parameters
Measured: 168 hours
cumulative urinary excretion rate, renal clearance (CLR168h)
PK parameters
Measured: 168 hours
Secondary outcomes (4)
Serum uric acid area under curve (AUCUA)
Pharmacodynamic Endpoints
Measured: 168 hours
cumulative excretion of uric acid (AeUA)
Pharmacodynamic Endpoints
Measured: 168 hours
renal clearance (CLRUA)
Pharmacodynamic Endpoints
Measured: 168 hours
serum creatinine area under curve (AUCCr)
Pharmacodynamic Endpoints
Measured: 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start29 May 2023
- Primary completion20 Dec 2023
- Study completion11 Jan 2024
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.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanton Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Li, Study director, Shanton Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678581
- Sponsor's protocol ID
- SAP-001-103
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single or Multiple Dose Escalation Study to Evaluate the Safety, PK Profile, PD Profile and Food Effects of SAP-001 Tablets in Healthy Chinese Subjects and Gout Patients With Hyperuricemia
- ClinicalTrials.gov ID
- NCT06678581
- Acronym / sponsor ID
- SAP-001-103
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shanton Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 7 Nov 2024 (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.
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia.
To evaluate the safety and tolerability of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacodynamics (PD) profile of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia.
To evaluate the pharmacokinetics profile of SAP-001 tablets in healthy Chinese subjects under fasted/fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAP-001 | Experimental | Drug: SAP-001Four sequentially ascending dose cohorts are set in SAD study. Three sequentially ascending dose cohorts are set in MAD study. |
| Placebo | Experimental | Drug: Placeboplacebo tablets for oral |
| A Randomized, Open-label, two-period crossover FE study | Experimental | Drug: SAP-00112 subjects are randomized in a 1:1 ratio to sequences A (fasting - fed) and B (fed - fasting). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female Chinese subjects between the ages of 18 and 55 years (inclusive of the cutoff value, the time of signing the informed consent shall prevail) in good health (as determined by medical history, physical examination, 12-lead ECG [heart rate > 50 bpm, PR interval < 200 ms, and QRS width < 120 ms], vital sign measurements, and normal or no clinically significant abnormalities in clinical laboratory evaluations as assessed by the investigator (or designee) at screening and Day -1);
- Body mass index between 18 and 28 kg/m2 (including the cutoff value) at screening, not less than 50 kg for men and 45 kg for women;
- Serum uric acid (sUA) level ≤ 420 μmol/L (7 mg/dL) during the screening period and no history of gout;
- Males and females of childbearing potential must agree to use at least one medically acceptable form of contraception (see Appendix for specific contraceptive measures) from screening through 3 months after the last dose;
- The subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form;
Key exclusion criteria (54 listed)
- Clinically abnormal diseases or factors, including but not limited to neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal system diseases or other factors, which investigator considered inappropriate for study participation;
- Subjects with a history of gastrointestinal surgery or resection (subjects who have undergone appendectomy and/or herniorrhaphy may be included in the study);
- Clinically significant liver function test abnormalities define as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times of the upper limit of normal (ULN) or total bilirubin (TBIL) > ULN at screening or baseline (D-1); or history of clinically significant acute or chronic hepatitis (including infectious, metabolic, autoimmune, hereditary, ischemic, or other forms), liver cirrhosis, or liver tumor.
- Subjects with a history of malignancy (excluding basal cell carcinoma) within 5 years before screening;
- History of acute infection within 14 days prior to screening;
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 |
|---|---|---|
| SAP-001Also: SAP-001 tabletSolid Oral Tablet | Drug | A Randomized, Open-label, two-period crossover FE study, SAP-001 |
| PlaceboAlso: placebo tabletSolid Oral Tablet | Drug | Placebo |
Primary outcome
maximum concentration (Cmax)
Time frame: 168 hours
PK parameters
area under the drug concentration-time curve from time 0 to the last measurable concentration sample collection time t (AUC0-t)
Time frame: 168 hours
PK parameters
area under the drug concentration-time curve from time 0 to 168 hours (AUC0-168h)
Time frame: 168 hours
PK parameters
time to maximum concentration (Tmax)
Time frame: 168 hours
PK parameters
elimination half-life (t1/2)
Time frame: 168 hours
PK parameters
cumulative urinary excretion from 0 to 168 h (Ae0-168h)
Time frame: 168 hours
PK parameters
cumulative urinary excretion rate, renal clearance (CLR168h)
Time frame: 168 hours
PK parameters
4 secondary outcomes
Serum uric acid area under curve (AUCUA)
Time frame: 168 hours
cumulative excretion of uric acid (AeUA)
Time frame: 168 hours
renal clearance (CLRUA)
Time frame: 168 hours
serum creatinine area under curve (AUCCr)
Time frame: 168 hours
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Li Li study director
Shanton Pharma Co., Ltd.
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 SAP-001 in people with Gout and Hyperuricemia, run by Shanton Pharma 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 14 inclusion and 54 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 12 Nov 2024. 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?
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?
maximum concentration (Cmax) (time frame: 168 hours). The study lists 7 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 12 Nov 2024.