Status:
UNKNOWN
Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
Lead Sponsor:
Newsoara Biopharma Co., Ltd.
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.
Detailed Description
This was a single center, Phase 1, open-label SAD and MAD study designed to assess safety, tolerability and PK of orally administered THR-1442 tablets in Chinese healthy adults. Subjects were enrolle...
Eligibility Criteria
Inclusion
- Be able to understand and be willing to sign informed consent and voluntarily participate in the study;
- Chinese women or men aged 18-45 (including 18 and 45) at the time of screening;
- 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;
- 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
- 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;
- Subjects with specific allergic history or allergic constitution such as drugs, food and pollen, or allergic to SGLT2 inhibitors or similar drugs;
- 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);
- Subjects with a history of bladder dysfunction, such as urinary incontinence, frequent urination or nocturia;
- Blood donation within 3 months before screening, including component blood or massive blood loss (≥ 200ml), receiving blood transfusion or using blood products;
- 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;
- 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;
- 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;
- The subject was unable to swallow the study drug or had gastrointestinal diseases leading to absorption disorders;
- Subjects who had participated in any drug or medical device clinical trial within 3 months before screening;
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05369078
Start Date
December 1 2021
End Date
May 31 2022
Last Update
May 11 2022
Active Locations (1)
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1
Hangzhou First People's hospital
Hangzhou, Zhejiang, China