T2DM (Type 2 Diabetes Mellitus)Phase 1NCT05369078
Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
A Phase 1 study testing THR-1442 20mg Single dose and THR-1442 20mg Multiple dose group in people with T2DM (Type 2 Diabetes Mellitus), run by Newsoara Biopharma Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- THR-1442 20mg Single dose and THR-1442 20mg Multiple dose group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)];
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's hospital
Hangzhou, Zhejiang
Fei Wang, hzsygcp@163.com
About this study
Official title: 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.
Read the 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)
- Being tested
- THR-1442 20mg Single dose, THR-1442 20mg Multiple dose group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THR-1442 20mg Single doseDrug
THR-1442 20mg is administrated 1 dose on Day 1, then follow till day 7.
THR-1442 20mg Multiple dose groupDrug
THR-1442 20mg is administrated QD for 7days, then follow till day 14.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: THR-1442 20mg Multiple dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters （AUC）
Measured: 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）
Measured: Single dose：Day1-Day7； Multiple dose：Day1- Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Dec 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study includes 2 parts: Single does part and multiple dose part. Single does part and multiple dose part are started same time.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newsoara Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369078
- Sponsor's protocol ID
- THR-1442-C-607 （CHN）
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT05369078
- Acronym / sponsor ID
- THR-1442-C-607 （CHN）
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Newsoara Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study includes 2 parts: Single does part and multiple dose part. Single does part and multiple dose part are started same time.
| Arm | Type | Receives |
|---|---|---|
| THR-1442 20mg Single dose group | Experimental | Drug: THR-1442 20mg Single doseTHR-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 | Experimental | Drug: THR-1442 20mg Multiple dose groupTHR-1442 20mg Multiple dose group: subject will be administrated THR-1442 20mg QD on Day1-Day7, the follow up till day 14. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)];
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THR-1442 20mg Single doseTHR-1442 20mg is administrated 1 dose on Day 1, then follow till day 7. | Drug | THR-1442 20mg Single dose group |
| THR-1442 20mg Multiple dose groupTHR-1442 20mg is administrated QD for 7days, then follow till day 14. | Drug | THR-1442 20mg Multiple dose group |
Primary outcome
Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study
Time frame: 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
2 secondary outcomes
Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study
Time frame: Single dose：Day1-Day7； Multiple dose：Day1- Day14
Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study
Time frame: Single dose：Day1-Day7； Multiple dose：Day1- Day14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THR-1442 20mg Single dose and THR-1442 20mg Multiple dose group in people with T2DM (Type 2 Diabetes Mellitus), run by Newsoara Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Owen Zhang (8621-52998027, owen.zhang@newsoara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study (time frame: Single dose：Baseline to day 7 ； Multiple dose：Baseline to Day14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.