DiabetesPhase 1NCT04119947
Single Ascending Oral Doses of SY-009 in Healthy Subjects
A Phase 1 study testing SY-009 in people with Diabetes, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-009 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- SY-009
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 30 May 2019
- 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
- 1、healthy subject：determined by medical history, physical examination, Imaging examination, abdominal B-mode ultrasonography (include liver, gallbladder, pancreas, spleen and kidney), electrocardiogram and laboratory tests. Test results within the normal range for the population or investigator site, or with abnormalities deemed clinically insignificant by the investigator; 2、Gender: Male and female, gender balance; 3、Age: 18-65 years old (including the boundary values); 4、Weight ≥50kg and 19.0kg/m2≤BMI≤28.0kg/m2 [BMI=body weight（kg）/height 2 (m2); 5、fasting plasm glucose (FPG): 3.9-6.1mmol/L (excluding the boundary valuses); 6、2h postprandial plasma giucose（2hPPG）<7.8mmol/L; 7、glycosylated hemoglobin (HbA1c) <5.7%;
- 8、have venous access sufficient to allow blood sampling as per the protocol;
- 9、Subjects must have informed consent before the study and sign a written informed consent form voluntarily;
- 10、Subjects can communicate well with investigator and complete the study according to the protocol.
Who cannot join
- are investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- within 3 months prior to screening, complete or withdraw a clinical study, or are currently conducting a clinical study. Or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- have previously completed or withdrawn from this study.
- have known allergies to compounds related to SY-009 capsules or its adjuvants,or allergic constitution/allergic history, or SGLT1 or SGLT2 inhibitors taken in the past one year.
- with cardiovascular diseases, respiratory diseases, gastrointestinal diseases, endocrine diseases, blood system diseases, nervous system diseases, disease status can significantly change the absorption, distribution, metabolism and excretion of experimental drugs, or taking experimental drugs will increase the risk of subjects.
- In the past five years, there has been a history of drug abuse or drug abuse tests positive.
Show all 18Show fewer
- show evidence or test positive on any of the following: hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV), Treponema pallidum antibody (S-TP), HIV (HIV1 + 2) antibody.
- Blood donation or massive blood loss exceeding 400 mL in the first three months prior to screening, or surgical operation and blood or blood component transfusion within the first four weeks prior to screening, or have history of fainting or needle fainting.
- Subjects who have an average weekly alcohol intake that exceeds and 14 units per week (1 unit = 360 mL beer, 45 mL alcohol content of 40% spirits or 150 mL wine) or subjects unwilling to stop alcohol consumption 24 hours prior to dosing until the completion of each inpatient study period.
- consume more than 5 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during the study.
- intend to use any medicine or health care product within 14 days prior to dosing or during the study.
- subjects not agree to use reliable contraceptive methods (hormones or barriers or abstinence) during the study period and at least 1 month after administration.
- women were positive for blood pregnancy test within 24 hours prior to enrollment.
- pregnant or lactating women.
- Have special dietary requirements，and impossible to comply with the unified diet.
- Unable to stop eating chocolate, any caffeine-containing food or beverage (such as pitaya, grapefruit, orange juice, mango, etc.) 48 hours before administration and during the study.
- Within 30 days prior to screening, any drugs that inhibit or induce drug metabolic enzymes in the liver (e.g. barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole, SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) were used.
- in the opinion of the investigator , are unsuitable for inclusion in the study，or subjects withdraw informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: Evaluation of Safety, Tolerance and Pharmacokinetics/Pharmacodynamics of SY-009 Capsules After Single Dose Incremental Oral Administration in Healthy Subjects
This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-009 in healthy subjects.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-009 capsule for Chinese healthy subjects. Plan to screening no more than 64 healthy subjects ， dividing them into 7 dose groups.
- Conditions
- Diabetes
- Being tested
- SY-009
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY-009Drug
The study will be initiated in healthy subjects at a 0.5mg dose that is the maximum recommended starting dose(MRSD) . Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 2,5, 10, 20, 40mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.
| Study group | Role | What they receive |
|---|---|---|
| SY-009 dose 1 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. Receives: Drug: SY-009 |
| SY-009 dose 2 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. Receives: Drug: SY-009 |
| SY-009 dose 3 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. Receives: Drug: SY-009 |
| SY-009 dose 4 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. Receives: Drug: SY-009 |
| SY-009 dose 5 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. Receives: Drug: SY-009 |
| SY-009 dose 6 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. Receives: Drug: SY-009 |
| SY-009 matching placebo | Placebo comparator | from 2-40mg Receives: Drug: SY-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Safety and tolerance of SY-009，Collecting Number of subjects with adverse events as assessed by CTCAE V5.0
Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal Laboratory Values, abnormal vital signs, Abnormal physical examination, Abnormal ECG data.
Measured: 7 Days
Secondary outcomes (7)
area under curve (AUC) of SY-009 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Measured: 3 Days
Cmax of SY-009 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Measured: 3 Days
T1/2 of SY-009 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Measured: 3 Days
CL/F (Clearance rectified) of SY-009 following oral administration of single ascending dose
to measure the study drug concentration in blood samples to be collected after drug administration.
Measured: 3 Days
glucose levels following single dose of SY-009
FPG AUC
Measured: 3 Days
insulin secretion following single dose of SY-009
insulin changes
Measured: 3 Days
C-peptide secretion following single dose of SY-009
C-peptide change
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Mar 2019
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Model description
- Parallel ，Placebo control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingtong Li, Doctor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119947
- Sponsor's protocol ID
- SY009001
- Status last verified
- Nov 2018
- First submitted
- 7 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Tolerance and Pharmacokinetics/Pharmacodynamics of SY-009 Capsules After Single Dose Incremental Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04119947
- Acronym / sponsor ID
- SY009001
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 9 Oct 2019 (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.
This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-009 in healthy subjects.
Detailed description
This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-009 capsule for Chinese healthy subjects. Plan to screening no more than 64 healthy subjects ， dividing them into 7 dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Parallel ，Placebo control
| Arm | Type | Receives |
|---|---|---|
| SY-009 dose 1 | Experimental | Drug: SY-009A single dose of SY-009 (0.5-40mg) taken orally. |
| SY-009 dose 2 | Experimental | Drug: SY-009A single dose of SY-009 (0.5-40mg) taken orally. |
| SY-009 dose 3 | Experimental | Drug: SY-009A single dose of SY-009 (0.5-40mg) taken orally. |
| SY-009 dose 4 | Experimental | Drug: SY-009A single dose of SY-009 (0.5-40mg) taken orally. |
| SY-009 dose 5 | Experimental | Drug: SY-009A single dose of SY-009 (0.5-40mg) taken orally. |
| SY-009 dose 6 | Experimental | Drug: SY-009A single dose of SY-009 (0.5-40mg) taken orally. |
| SY-009 matching placebo | Placebo comparator | Drug: SY-009from 2-40mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1、healthy subject：determined by medical history, physical examination, Imaging examination, abdominal B-mode ultrasonography (include liver, gallbladder, pancreas, spleen and kidney), electrocardiogram and laboratory tests. Test results within the normal range for the population or investigator site, or with abnormalities deemed clinically insignificant by the investigator; 2、Gender: Male and female, gender balance; 3、Age: 18-65 years old (including the boundary values); 4、Weight ≥50kg and 19.0kg/m2≤BMI≤28.0kg/m2 [BMI=body weight（kg）/height 2 (m2); 5、fasting plasm glucose (FPG): 3.9-6.1mmol/L (excluding the boundary valuses); 6、2h postprandial plasma giucose（2hPPG）<7.8mmol/L; 7、glycosylated hemoglobin (HbA1c) <5.7%;
- 8、have venous access sufficient to allow blood sampling as per the protocol;
- 9、Subjects must have informed consent before the study and sign a written informed consent form voluntarily;
- 10、Subjects can communicate well with investigator and complete the study according to the protocol.
Key exclusion criteria (18 listed)
- are investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- within 3 months prior to screening, complete or withdraw a clinical study, or are currently conducting a clinical study. Or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- have previously completed or withdrawn from this study.
- have known allergies to compounds related to SY-009 capsules or its adjuvants,or allergic constitution/allergic history, or SGLT1 or SGLT2 inhibitors taken in the past one year.
- with cardiovascular diseases, respiratory diseases, gastrointestinal diseases, endocrine diseases, blood system diseases, nervous system diseases, disease status can significantly change the absorption, distribution, metabolism and excretion of experimental drugs, or taking experimental drugs will increase the risk of subjects.
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 |
|---|---|---|
| SY-009The study will be initiated in healthy subjects at a 0.5mg dose that is the maximum recommended starting dose(MRSD) . Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 2,5, 10, 20, 40mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review. | Drug | SY-009 dose 1, SY-009 dose 2, SY-009 dose 3, SY-009 dose 4, SY-009 dose 5, SY-009 dose 6, SY-009 matching placebo |
Primary outcome
The Safety and tolerance of SY-009，Collecting Number of subjects with adverse events as assessed by CTCAE V5.0
Time frame: 7 Days
Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal Laboratory Values, abnormal vital signs, Abnormal physical examination, Abnormal ECG data.
7 secondary outcomes
area under curve (AUC) of SY-009 following oral administration of single ascending dose
Time frame: 3 Days
Cmax of SY-009 following oral administration of single ascending dose
Time frame: 3 Days
T1/2 of SY-009 following oral administration of single ascending dose
Time frame: 3 Days
CL/F (Clearance rectified) of SY-009 following oral administration of single ascending dose
Time frame: 3 Days
glucose levels following single dose of SY-009
Time frame: 3 Days
insulin secretion following single dose of SY-009
Time frame: 3 Days
C-peptide secretion following single dose of SY-009
Time frame: 3 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 10 Oct 2019.
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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.
Jingtong Li, Doctor principal investigator
China-Japan Friendship Hospital
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 SY-009 in people with Diabetes, run by Suzhou Yabao Pharmaceutical R&D 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 4 inclusion and 18 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 10 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
The Safety and tolerance of SY-009，Collecting Number of subjects with adverse events as assessed by CTCAE V5.0 (time frame: 7 Days). 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 10 Oct 2019.