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

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.

Study Overview

• Status: Recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: THR-1442 20mg Single dose; Drug: THR-1442 20mg Multiple dose group

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Hangzhou First People's Hospital
      • Contact: Fei Wang; Email: hzsygcp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: THR-1442 20mg Single dose; THR-1442 20mg is administrated 1 dose on Day 1, then follow till day 7.
EXPERIMENTAL: 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.	Drug: THR-1442 20mg Multiple dose group; THR-1442 20mg is administrated QD for 7days, then follow till day 14.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Newsoara Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (ACTUAL): May 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: THR-1442-C-607 （CHN）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No