Single Ascending Oral Doses of SY-008 in Healthy Subjects

NCT03462589 | Completed Phase 1

• 1 other identifier: SY008001
• Study Type: interventional
• Target: 54
• 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-008 in healthy subjects.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (7)

• area under curve (AUC) of SY-008 following oral administration of single ascending dose

  3 days

• Cmax of SY-008 following oral administration of single ascending dose

  3 days

• T1/2 of SY-008 following oral administration of single ascending dose

  3 days

• CL/F (Clearance rectified) of SY-008 following oral administration of single ascending dose

  3 days

• glucose levels following single dose of SY-008

  24 hours

Study Arms (6)

SY-008 dose 1

EXPERIMENTAL

A single dose of SY-008 (2\~30mg) taken orally.

Drug: SY-008

SY-008 dose 2

EXPERIMENTAL

A single dose of SY-008 (2\~30mg) taken orally.

Drug: SY-008

SY-008 dose 3

EXPERIMENTAL

A single dose of SY-008 (2\~30mg) taken orally.

Drug: SY-008

SY-008 dose 4

EXPERIMENTAL

A single dose of SY-008 (2\~30mg) taken orally.

Drug: SY-008

SY-008 dose 5

EXPERIMENTAL

A single dose of SY-008 (2\~30mg) taken orally.

Drug: SY-008

SY-008 matching placebo

PLACEBO COMPARATOR

from 6mg to 30mg

Drug: SY-008

Interventions

SY-008 DRUG

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.

SY-008 dose 1; SY-008 dose 2; SY-008 dose 3; SY-008 dose 4; SY-008 dose 5; SY-008 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:

• 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.
• 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.

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.
• h 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Feng Shao, Doctor

  The Frist Affiliated Hospital Of Nanjing Madical University

  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

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: March 12, 2018
• Study Start: August 2, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)