Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects

NCT ID: NCT05369078

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-05-31

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

THR-1442 20mg Single dose group

THR-1442 20mg Single dose group: subject will be administrated 1 dose of 20mg THR-1442 on day1, the follow up till day 7.

Group Type: EXPERIMENTAL

THR-1442 20mg Single dose

Intervention Type: DRUG

THR-1442 20mg is administrated 1 dose on Day 1, then follow till day 7.

THR-1442 20mg Multiple dose group

THR-1442 20mg Multiple dose group: subject will be administrated THR-1442 20mg QD on Day1-Day7, the follow up till day 14.

Group Type: EXPERIMENTAL

THR-1442 20mg Multiple dose group

Intervention Type: DRUG

THR-1442 20mg is administrated QD for 7days, then follow till day 14.

Interventions

THR-1442 20mg Single dose

THR-1442 20mg is administrated 1 dose on Day 1, then follow till day 7.

Intervention Type: DRUG

THR-1442 20mg Multiple dose group

THR-1442 20mg is administrated QD for 7days, then follow till day 14.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Newsoara Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hangzhou First People's hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Owen Zhang

Role: CONTACT

owen.zhang@newsoara.com

8621-52998027

Facility Contacts

Fei Wang

Role: primary

hzsygcp@163.com

Other Identifiers

THR-1442-C-607 （CHN）

Identifier Type: -

Identifier Source: org_study_id