T2DM (Type 2 Diabetes Mellitus) Clinical Trial
Official title:
Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Be able to understand and be willing to sign informed consent and voluntarily participate in the study; 2. Chinese women or men aged 18-45 (including 18 and 45) at the time of screening; 3. Men or women who agree to effective contraception from the screening period until 30 days after the last dose in the trial; Agree to take at least one effective contraceptive measure; 4. During screening and baseline, male weight = 50.0kg, female weight = 45.0kg, body mass index (BMI) in the range of 19 ~ 25.0kg/m2 (including 19 and 25.0kg/m2), [BMI = weight (kg) / height 2 (M2)]; Exclusion Criteria: 1. According to the judgment of the site investigators, including clinical significant medical history in CNS, CV system, respiratory system, blood / hematopoietic system, gastrointestinal system, liver / kidney system,etc; 2. Subjects with specific allergic history or allergic constitution such as drugs, food and pollen, or allergic to SGLT2 inhibitors or similar drugs; 3. Alcoholics (drinking 14 units per week, each unit equivalent to 360mL beer or 150mL wine or 45mL alcohol of 40% alcohol), drug or drug dependence subjects; Smokers (smoking > 5 cigarettes per day or the same amount of other tobacco products); 4. Subjects with a history of bladder dysfunction, such as urinary incontinence, frequent urination or nocturia; 5. Blood donation within 3 months before screening, including component blood or massive blood loss (= 200ml), receiving blood transfusion or using blood products; 6. Subjects who used prescription drugs, traditional Chinese medicine, over-the-counter drugs (OTC), vitamins, dietary supplements or supplements (e.g. ginseng) within 4 weeks before the first administration; 7. From 7 days before the first dose to the whole study period, subjects who are unwilling or unable to guarantee to forbid by the following: no smoking, no alcohol, no caffeine containing products (including chocolate, tea, coffee, cola, etc.) and avoid strenuous exercise; 8. Those who are unwilling or unable to guarantee to forbid pitaya, grapefruit, mango, carambola, fruit juice and spicy food containing the above fruits from 7 days before taking the medicine and the whole test period; 9. The subject was unable to swallow the study drug or had gastrointestinal diseases leading to absorption disorders; 10. Subjects who had participated in any drug or medical device clinical trial within 3 months before screening; |
Country | Name | City | State |
---|---|---|---|
China | Hangzhou First People's hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Newsoara Biopharma Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study | Collect data(TEAEs including clinical AEs and lab AEs) on Day7 and Day14 to evaluate THR1442 safety and tolerability | Single dose:Baseline to day 7 ; Multiple dose:Baseline to Day14 | |
Secondary | Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study | Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters (AUC) | Single dose:Day1-Day7; Multiple dose:Day1- Day14 | |
Secondary | Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study | Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters (Cmax) | Single dose:Day1-Day7; Multiple dose:Day1- Day14 |
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