HyperglycemiaPhase 1NCT07327281
A Clinical Trial Evaluating TQF3250 Capsules in Healthy Adult Subjects
A Phase 1 study testing TQF3250 capsule in people with Hyperglycemia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- TQF3250 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese subjects aged above 18 years old (including 18 years old) and below 55 years old (including 55 years old);
- Those who voluntarily sign a written informed consent form before the trial, have a full understanding of the trial content, process and possible adverse reactions, can communicate well with the researcher, and understand and comply with the requirements of this study;
- Women of childbearing potential should agree to use effective contraceptive measures during the study and for 6 months after the end of the study;
- Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 20-40kg/m2 (including both ends of the cutoff);
Who cannot join
- Pregnant and lactating women.
- Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, anteroposterior chest X-ray, and abdominal ultrasound results during the screening period are abnormal and have clinical significance.
- Those who have had or currently have diseases/abnormalities such as heart, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, blood, nerve or mental illness, or related chronic diseases, or acute diseases, and the researcher assesses that they are not suitable to participate in the trial:
- Have active tuberculosis during the screening period, or be a close household contact of an untreated active tuberculosis patient.
- Have a history of severe bacterial, fungal or viral infection within 2 months before randomization, requiring hospitalization with intravenous antibiotics or antiviral drug treatment;
- Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;
Show all 25Show fewer
- Subjects with any bleeding or bleeding events ≥ Common Terminology Criteria (CTC) AE grade 3 within 4 weeks before the first dose;
- Clinically significant infections occur during the screening period, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, and require antibiotic or antiviral drug treatment.
- Have a history of severe herpes zoster or herpes simplex infection, including but not limited to herpetic encephalitis, disseminated herpes simplex, and generalized herpes zoster.
- Use any systemic cytotoxic or systemic immunosuppressive drugs within 6 months before randomization or within the study period, or use any local cytotoxic or local immunosuppressive drugs within 4 weeks before randomization or within 5 half-lives (whichever is longer) or during the study period.
- Have received any other biological agents on the market or under investigation within 3 months or 5 half-lives (whichever is longer) before randomization.
- Have received a live vaccine within 4 weeks before randomization or plan to receive a live vaccine during the study.
- Those who have undergone surgery within 4 weeks before randomization, or plan to have surgery during the study period.
- Those who lost blood or donated more than 400 mL of blood within 4 weeks before randomization.
- Taking any prescription drugs, non-prescription drugs and herbal medicines within 4 weeks before randomization, except vitamin products.
- Those who have difficulty collecting blood and have a history of fainting from needles or bleeding.
- Are allergic to any known ingredients of TQF3250 capsules, or have any history of severe drug allergy.
- Those with a history of drug abuse or positive urine drug screening.
- Those who smoke more than 5 cigarettes/day or use a considerable amount of nicotine or nicotine-containing products within 3 months before randomization, or who cannot stop using any tobacco products during the trial.
- Those who have been alcoholics for a long time or who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) within 3 months before screening, or who cannot abstain from alcohol during the test, or who have a positive alcohol breath test.
- Those who habitually consume too many caffeinated drinks or foods within 4 weeks before screening. Have consumed grapefruit, bitter orange and the juice of these fruits within 7 days before the first dose, or cannot stop consuming grapefruit, bitter orange and the juice of these fruits during the study;
- Those who have special dietary requirements and cannot accept standard diet;
- There are any other reasonable medical, mental or social reasons that the researcher believes to be unable to participate in this study.
- Those who are unable to comply with the trial plan;
- Those who participated in and used other clinical trial drugs within three months before the first medication;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu, 210008
Juan Li, Doctor, 15951989771, juanli2003@163.com
About this study
Official title: A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQF3250 Capsules in Healthy Adult Subjects After Single Administration and Escalating Doses
TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.
- Conditions
- Hyperglycemia
- Being tested
- TQF3250 placebo, TQF3250 capsule
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQF3250 placeboDrug
TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.
TQF3250 capsuleDrug
TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.
| Study group | Role | What they receive |
|---|---|---|
| TQF3250 placebo | Placebo comparator | Placebo without drug substance. Receives: Drug: TQF3250 placebo |
| TQF3250 capsule | Experimental | Oral administration, the fasting administration group was administered once, and the food-influenced group was administered once per cycle, for a total of two cycles. Each cycle is 10 days. Receives: Drug: TQF3250 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs).
Measured: Up to 20 days
Number of participants with abnormal clinical laboratory test indicators
Number of participants with abnormal clinical laboratory test indicators.
Measured: Up to 20 days
Changes in body temperature after using TQF3250 capsules
Evaluate changes in body temperature after using TQF3250 capsules
Measured: Up to 24 hour
Tolerance assessment: 12-lead electrocardiogram
Tolerance assessment: 12-lead electrocardiogram
Measured: Up to 20 days
Changes in pulse/heart rate after use of TQF3250 capsules
Changes in pulse/heart rate after use of TQF3250 capsules
Measured: Up to 24 hour
Changes in respiratory rate after using TQF3250 capsules
Evaluate changes in respiratory rate after using TQF3250 capsules
Measured: Up to 24 hour
Changes in blood pressure after using TQF3250 capsules
To evaluate the changes in blood pressure after using TQF3250 capsules
Measured: Up to 24 hour
Changes in blood oxygen saturation after using TQF3250 capsules
Evaluate changes in blood oxygen saturation after using TQF3250 capsules
Measured: Up to 24 hour
Secondary outcomes (8)
Peak drug concentration (Cmax)
It refers to the highest blood concentration reached after administration of TQF3250 capsules.
Measured: Within 20 days after administration
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t).
Measured: Within 20 days after administration
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞).
Measured: Within 20 days after administration
Peak time (Tmax)
It refers to the time it takes for TQF3250 capsules to reach the highest blood concentration after administration.
Measured: Within 20 days after administration
To evaluate the AUC0-t of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial
To evaluate the AUC0-t of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial.
Measured: Up to 20 days
To evaluate the AUC0-∞ of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial
To evaluate the AUC0-∞ of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial.
Measured: Up to 20 days
Evaluate the geometric mean Cmax of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial
Evaluate the geometric mean Cmax of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial.
Measured: Up to 20 days
Evaluate 90% confidence intervals for TQF3250 capsules and possible metabolites
Evaluate 90% confidence intervals for TQF3250 capsules and possible metabolites.
Measured: Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start18 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327281
- Sponsor's protocol ID
- TQF3250-Ia-01
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQF3250 Capsules in Healthy Adult Subjects After Single Administration and Escalating Doses
- ClinicalTrials.gov ID
- NCT07327281
- Acronym / sponsor ID
- TQF3250-Ia-01
- Conditions
- Hyperglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQF3250 placebo | Placebo comparator | Drug: TQF3250 placeboPlacebo without drug substance. |
| TQF3250 capsule | Experimental | Drug: TQF3250 capsuleOral administration, the fasting administration group was administered once, and the food-influenced group was administered once per cycle, for a total of two cycles. Each cycle is 10 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese subjects aged above 18 years old (including 18 years old) and below 55 years old (including 55 years old);
- Those who voluntarily sign a written informed consent form before the trial, have a full understanding of the trial content, process and possible adverse reactions, can communicate well with the researcher, and understand and comply with the requirements of this study;
- Women of childbearing potential should agree to use effective contraceptive measures during the study and for 6 months after the end of the study;
- Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 20-40kg/m2 (including both ends of the cutoff);
Key exclusion criteria (25 listed)
- Pregnant and lactating women.
- Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, anteroposterior chest X-ray, and abdominal ultrasound results during the screening period are abnormal and have clinical significance.
- Those who have had or currently have diseases/abnormalities such as heart, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, blood, nerve or mental illness, or related chronic diseases, or acute diseases, and the researcher assesses that they are not suitable to participate in the trial:
- Have active tuberculosis during the screening period, or be a close household contact of an untreated active tuberculosis patient.
- Have a history of severe bacterial, fungal or viral infection within 2 months before randomization, requiring hospitalization with intravenous antibiotics or antiviral drug treatment;
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 |
|---|---|---|
| TQF3250 placeboTQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects. | Drug | TQF3250 placebo |
| TQF3250 capsuleTQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects. | Drug | TQF3250 capsule |
Primary outcome
Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
Time frame: Up to 20 days
Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs).
Number of participants with abnormal clinical laboratory test indicators
Time frame: Up to 20 days
Number of participants with abnormal clinical laboratory test indicators.
Changes in body temperature after using TQF3250 capsules
Time frame: Up to 24 hour
Evaluate changes in body temperature after using TQF3250 capsules
Tolerance assessment: 12-lead electrocardiogram
Time frame: Up to 20 days
Tolerance assessment: 12-lead electrocardiogram
Changes in pulse/heart rate after use of TQF3250 capsules
Time frame: Up to 24 hour
Changes in pulse/heart rate after use of TQF3250 capsules
Changes in respiratory rate after using TQF3250 capsules
Time frame: Up to 24 hour
Evaluate changes in respiratory rate after using TQF3250 capsules
Changes in blood pressure after using TQF3250 capsules
Time frame: Up to 24 hour
To evaluate the changes in blood pressure after using TQF3250 capsules
Changes in blood oxygen saturation after using TQF3250 capsules
Time frame: Up to 24 hour
Evaluate changes in blood oxygen saturation after using TQF3250 capsules
8 secondary outcomes
Peak drug concentration (Cmax)
Time frame: Within 20 days after administration
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)
Time frame: Within 20 days after administration
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Within 20 days after administration
Peak time (Tmax)
Time frame: Within 20 days after administration
To evaluate the AUC0-t of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial
Time frame: Up to 20 days
To evaluate the AUC0-∞ of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial
Time frame: Up to 20 days
Evaluate the geometric mean Cmax of TQF3250 capsules and possible metabolites under two administration methods: fasting and postprandial
Time frame: Up to 20 days
Evaluate 90% confidence intervals for TQF3250 capsules and possible metabolites
Time frame: Up to 20 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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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.
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 TQF3250 capsule in people with Hyperglycemia, run by Chia Tai Tianqing Pharmaceutical Group 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 25 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Li, Doctor (15951989771, juanli2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) (time frame: Up to 20 days). The study lists 8 primary outcomes in all. 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 8 Jan 2026.