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

NCT05369078 | Unknown Phase 1

• 1 other identifier: THR-1442-C-607 （CHN）
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study

  Single dose：Day1-Day7； Multiple dose：Day1- Day14

• Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study

  Single dose：Day1-Day7； Multiple dose：Day1- Day14

Study Arms (2)

THR-1442 20mg Single dose group

EXPERIMENTAL

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 Multiple dose group

EXPERIMENTAL

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

Interventions

THR-1442 20mg Single dose DRUG

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

THR-1442 20mg Single dose group

THR-1442 20mg Multiple dose group DRUG

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

THR-1442 20mg Multiple dose group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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), \[BMI = weight (kg) / height 2 (M2)\];

You may not qualify if:

• 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;

Sponsors & Collaborators

• Newsoara Biopharma Co., Ltd.: lead

Study Sites (1)

Hangzhou First People's hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Owen Zhang

CONTACT

8621-52998027; owen.zhang@newsoara.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study includes 2 parts: Single does part and multiple dose part. Single does part and multiple dose part are started same time.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: May 11, 2022
• Study Start: December 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: May 11, 2022

Record last verified: 2021-12

Locations

CN (1)