Clinical trial NCT05369078: Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Newsoara Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study includes 2 parts: Single does part and multiple dose part. Single does part and multiple dose part are started same time.
Primary purpose: TREATMENT

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 enrolled to receive 20mg THR-1442 tablet in Single dose group (20mg\*1 day) and multiple dose group(20mg\*7days).

Blood samples for THR-1442 plasma concentrations were collected 0h till to 48hours.

Eligibility criteria: 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;

Primary outcomes:
measure: Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study
timeFrame: Single dose：Baseline to day 7 ； Multiple dose：Baseline to Day14
Secondary outcomes:
measure: Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study
timeFrame: Single dose：Day1-Day7； Multiple dose：Day1- Day14
measure: Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study
timeFrame: Single dose：Day1-Day7； Multiple dose：Day1- Day14
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's hospital
state: Zhejiang
Study officials:
References: