DiabetesPhase 1NCT03462589
Single Ascending Oral Doses of SY-008 in Healthy Subjects
A Phase 1 study testing SY-008 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-008 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-008
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2018to 30 Dec 2018
- 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
- Gender: Male and female, gender balance.
- Age: 18-65 years old (including the boundary values).
- Weight ≥50kg and 19kg / m2 ≤ BMI ≤ 28kg / m2 [BMI = body weight (kg) / height 2 (m2).
- fasting plasm glucose (FPG): 3.9-6.1mmol / L (excluding the boundary values).
- glycosylated hemoglobin (HbA1c) <6.5%.
- healthy subjects determined by medical history, physical examination, 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.
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- have venous access sufficient to allow blood sampling as per the protocol.
- have given written informed consent approved by sponsors and the ethical review board governing the site.
- are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
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.
- 2h postprandial plasm glucose (2hPPG) ≥7.8 mmol / L（Test on -1 Day）.
- have known allergies to compounds related to SY-008 capsules or multiple drug allergies, or have been treated with SGLT-1(sodium-glucose cotransporter-1) inhibitors in 1 year.
- have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (such as hemorrhoids, inflammation of GI tract, tumor, history of surgery, habitual bellyache or diarrheal disorders, other motility disorders), endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data.
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- have a history of alcohol abuse or drug abuse.
- show evidence or test positive on any of the following: hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV), Treponema pallidum antibody (TP), HIV (HIV1 + 2) antibody.
- have donated blood of 400 mL or more in the last 3 months or provided any blood donation within the last month from screening.
- are subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females; 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits) or are subjects unwilling to stop alcohol consumption 24 hours prior to dosing until the completion of each inpatient study period.
- consume more than 10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during the study.
- intend to use over-the-counter or prescription medications 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.
- in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Dose Escalated Tolerance and Pharmacokinetic / Pharmacodynamic Studies of SY-008 Capsules Administered by Chinese Healthy Subjects
This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-008 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-008 capsule for Chinese healthy subjects. Plan to screening total of 54 healthy subjects ， dividing them into 6 dose groups.
- Conditions
- Diabetes
- Being tested
- SY-008
- 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-008Drug
The study will be initiated in healthy subjects at a 2-mg dose that is expected to have minimal pharmacologic effect. Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 6, 12, 18, 24, 30mg 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-008 dose 1 | Experimental | A single dose of SY-008 (2~30mg) taken orally. Receives: Drug: SY-008 |
| SY-008 dose 2 | Experimental | A single dose of SY-008 (2~30mg) taken orally. Receives: Drug: SY-008 |
| SY-008 dose 3 | Experimental | A single dose of SY-008 (2~30mg) taken orally. Receives: Drug: SY-008 |
| SY-008 dose 4 | Experimental | A single dose of SY-008 (2~30mg) taken orally. Receives: Drug: SY-008 |
| SY-008 dose 5 | Experimental | A single dose of SY-008 (2~30mg) taken orally. Receives: Drug: SY-008 |
| SY-008 matching placebo | Placebo comparator | from 6mg to 30mg Receives: Drug: SY-008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Measured: 7 days
Secondary outcomes (7)
area under curve (AUC) of SY-008 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-008 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-008 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-008 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-008
FPG AUC
Measured: 24 hours
insulin secretion following single dose of SY-008
insulin changes
Measured: 3 days
C-peptide secretion following single dose of SY-008
C-peptide change
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start2 Aug 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng Shao, Doctor, Principal investigator, The Frist Affiliated Hospital Of Nanjing Madical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462589
- Sponsor's protocol ID
- SY008001
- Status last verified
- Oct 2019
- First submitted
- 11 Feb 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Randomized, Double-blind, Placebo-controlled, Dose Escalated Tolerance and Pharmacokinetic / Pharmacodynamic Studies of SY-008 Capsules Administered by Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT03462589
- Acronym / sponsor ID
- SY008001
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 12 Mar 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.
This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-008 in healthy subjects.
Detailed description
This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-008 capsule for Chinese healthy subjects. Plan to screening total of 54 healthy subjects ， dividing them into 6 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
- 6
| Arm | Type | Receives |
|---|---|---|
| SY-008 dose 1 | Experimental | Drug: SY-008A single dose of SY-008 (2~30mg) taken orally. |
| SY-008 dose 2 | Experimental | Drug: SY-008A single dose of SY-008 (2~30mg) taken orally. |
| SY-008 dose 3 | Experimental | Drug: SY-008A single dose of SY-008 (2~30mg) taken orally. |
| SY-008 dose 4 | Experimental | Drug: SY-008A single dose of SY-008 (2~30mg) taken orally. |
| SY-008 dose 5 | Experimental | Drug: SY-008A single dose of SY-008 (2~30mg) taken orally. |
| SY-008 matching placebo | Placebo comparator | Drug: SY-008from 6mg to 30mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gender: Male and female, gender balance.
- Age: 18-65 years old (including the boundary values).
- Weight ≥50kg and 19kg / m2 ≤ BMI ≤ 28kg / m2 [BMI = body weight (kg) / height 2 (m2).
- fasting plasm glucose (FPG): 3.9-6.1mmol / L (excluding the boundary values).
- glycosylated hemoglobin (HbA1c) <6.5%.
Key exclusion criteria (16 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.
- 2h postprandial plasm glucose (2hPPG) ≥7.8 mmol / L（Test on -1 Day）.
- have known allergies to compounds related to SY-008 capsules or multiple drug allergies, or have been treated with SGLT-1(sodium-glucose cotransporter-1) inhibitors in 1 year.
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-008The study will be initiated in healthy subjects at a 2-mg dose that is expected to have minimal pharmacologic effect. Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 6, 12, 18, 24, 30mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review. | Drug | SY-008 dose 1, SY-008 dose 2, SY-008 dose 3, SY-008 dose 4, SY-008 dose 5, SY-008 matching placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 7 days
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
7 secondary outcomes
area under curve (AUC) of SY-008 following oral administration of single ascending dose
Time frame: 3 days
Cmax of SY-008 following oral administration of single ascending dose
Time frame: 3 days
T1/2 of SY-008 following oral administration of single ascending dose
Time frame: 3 days
CL/F (Clearance rectified) of SY-008 following oral administration of single ascending dose
Time frame: 3 days
glucose levels following single dose of SY-008
Time frame: 24 hours
insulin secretion following single dose of SY-008
Time frame: 3 days
C-peptide secretion following single dose of SY-008
Time frame: 6 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 10 Oct 2019.
- 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.
Feng Shao, Doctor principal investigator
The Frist Affiliated Hospital Of Nanjing Madical 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 SY-008 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 9 inclusion and 16 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (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; AzTrials last refreshed its copy on 8 Nov 2026.