Single Ascending Oral Doses of SY-009 in Healthy Subjects

NCT04119947 | Completed Phase 1

• 1 other identifier: SY009001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-009 in healthy subjects.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  7 Days

Secondary Outcomes (7)

• area under curve (AUC) of SY-009 following oral administration of single ascending dose

  3 Days

• Cmax of SY-009 following oral administration of single ascending dose

  3 Days

• T1/2 of SY-009 following oral administration of single ascending dose

  3 Days

• CL/F (Clearance rectified) of SY-009 following oral administration of single ascending dose

  3 Days

• glucose levels following single dose of SY-009

  3 Days

Study Arms (7)

SY-009 dose 1

EXPERIMENTAL

A single dose of SY-009 (0.5-40mg) taken orally.

Drug: SY-009

SY-009 dose 2

EXPERIMENTAL

A single dose of SY-009 (0.5-40mg) taken orally.

Drug: SY-009

SY-009 dose 3

EXPERIMENTAL

A single dose of SY-009 (0.5-40mg) taken orally.

Drug: SY-009

SY-009 dose 4

EXPERIMENTAL

A single dose of SY-009 (0.5-40mg) taken orally.

Drug: SY-009

SY-009 dose 5

EXPERIMENTAL

A single dose of SY-009 (0.5-40mg) taken orally.

Drug: SY-009

SY-009 dose 6

EXPERIMENTAL

A single dose of SY-009 (0.5-40mg) taken orally.

Drug: SY-009

SY-009 matching placebo

PLACEBO COMPARATOR

from 2-40mg

Drug: SY-009

Interventions

SY-009 DRUG

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 、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%;
• 、have venous access sufficient to allow blood sampling as per the protocol;
• 、Subjects must have informed consent before the study and sign a written informed consent form voluntarily;
• 、Subjects can communicate well with investigator and complete the study according to the protocol.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Suzhou Yabao Pharmaceutical R&D Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jingtong Li, Doctor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel ，Placebo control

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: March 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: October 10, 2019

Record last verified: 2018-11

Locations

CN (1)