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

Phase 1

• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: THR-1442 20mg Single dose; Drug: THR-1442 20mg Multiple dose group

• Registration Number: NCT05369078
• Lead Sponsor: Newsoara Biopharma Co., Ltd.

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.

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-01
• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-05
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study	Single dose：Baseline to day 7 ； Multiple dose：Baseline to Day14	Collect data(TEAEs including clinical AEs and lab AEs) on Day7 and Day14 to evaluate THR1442 safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study	Single dose：Day1-Day7； Multiple dose：Day1- Day14	Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters （Cmax）
Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study	Single dose：Day1-Day7； Multiple dose：Day1- Day14	Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters （AUC）

Trial Locations

Locations (1)

Hangzhou First People's hospital; 🇨🇳 Hangzhou, Zhejiang, China