Diabetes Mellitus, Type 2Phase 1NCT06143423
A Clinical Trial of AP026 (TQA2226) for Injection in Adult Subjects.
A Phase 1 study testing AP026 (TQA2226) for injection in people with Diabetes Mellitus, Type 2, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study was a randomized, double-blind, placebo-controlled phase I clinical trial of AP026 (TQA2226) for injection in adult healthy subjects, which planned to recruit 74 healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- AP026 (TQA2226) for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2023to 16 Mar 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign an informed consent form before the study and have a thorough understanding of the content, process, and potential adverse reactions of the study;
- Able to complete the study according to the requirements of the protocol;
- Subjects (including their partners) are willing to voluntarily take effective contraceptive measures within 6 months after the last study drug administration;
- Male and female subjects aged 18-55 (inclusive);
- Male subjects weighing no less than 50 kilograms and female subjects weighing no less than 45 kilograms, With a body mass index within the range of 18~28kg/m2 (inclusive);
- Physical examination and vital signs are normal or abnormal but with no clinical significance (judged by the investigators).
Who cannot join
- Pregnant and lactating women;
- There are abnormal and clinically significant clinical laboratory examination results, or clinically significant diseases within 12 months before screening, which is not recommended to participate in the trial after evaluation by the investigators. Subjects with a previous medical history but are recovered with clinical evidence can be included in this study;
- During the screening period, any one of the vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, and other auxiliary examination results is abnormal and judged by the investigator to have clinical significance;
- Subjects who test positive for any of the hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (Anti HCV), human immunodeficiency virus antibody (Anti HIV), and Treponema pallidum antibody (Anti TP);
- Those who have undergone surgery within 4 weeks before screening or plan to undergo surgery during the study period;
- Received investigational drugs or participated in clinical trials within 3 months prior to screening;
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- Received immunoglobulin or blood products within 30 days before randomization;
- Donated blood (> 300 mL) or experienced significant blood loss (> 400 mL) within 3 months prior to screening;
- Subjects with a history of needle sickness, blood sickness, or potential difficult in collecting blood;
- History of allergic reactions to other therapeutic monoclonal antibodies or biological agents, or history of allergies to multiple drugs or foods, especially to ingredients similar to the study drug;
- Smoking more than 5 cigarettes per day or using an equivalent amount of nicotine or nicotine containing products within 3 months before randomization, or failing to stop using any tobacco products during the trial period;
- Those who have been drinking excessively for a long time or have consumed more than 14 units of alcohol per week within 3 months before screening, or cannot abstain from alcohol during the trial period, or have tested positive for alcohol breath test;
- Subjects with a history of drug abuse, or positive urine drug screening;
- Received any commercially available or investigational biological agents within 4 months before randomization or within 5 half-lives of drugs (whichever is longer);
- Within 4 weeks before randomization, received any systemic prescription drugs, over-the-counter drugs, herbs, any vitamin products, and health products, or any topical drugs of the above forms at the injection site of this study;
- From the screening period to the study medication, acute diseases or concomitant medication occured.
- Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
- Any situation that the investigator believes will pose a safety risk to the subject during the study or may interfere with the implementation of this study, or the investigator believes that the subject may not be able to complete this study or may not be able to comply with the requirements of this study.
- QT interval > 450 milliseconds, or electrocardiogram is not suitable for Concentration-QT measurement (according to the judgment of the investigator).
- History of risk factors for torsade de pointe ventricular tachycardia. Subject with a family history of long QT syndrome or Brugada syndrome will also be excluded.
- Heart rate ≤ 45 bpm.
- History of renal or liver dysfunction.
- History or condition of cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate AP026 (TQA2226) for Injection in Adult Subjects After Single/Multiple Administration.
This study was a randomized, double-blind, placebo-controlled phase I clinical trial of AP026 (TQA2226) for injection in adult healthy subjects, which planned to recruit 74 healthy subjects. The main purpose was to evaluate the safety and tolerance of AP026 (TQA2226) for injection after single and multiple doses in healthy subjects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- AP026 (TQA2226) for injection, AP026 (TQA2226) for injection matching placebo
- 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.
AP026 (TQA2226) for injectionDrug
AP026 (TQA2226) for injection is a GLP-1-FGF21-Fc bifunctional fusion protein.
AP026 (TQA2226) for injection matching placeboDrug
AP026 (TQA2226) for injection matching placebo is a placebo produced according to AP026 (TQA2226) for injection, and has no effect on GLP-1 and FGF21.
| Study group | Role | What they receive |
|---|---|---|
| AP026 (TQA2226) for injection Single administration dose (SAD) | Experimental | AP026 (TQA2226) for injection, administered once. Receives: Drug: AP026 (TQA2226) for injection |
| AP026 (TQA2226) for injection matching placebo Single administration dose (SAD) | Placebo comparator | AP026 (TQA2226) for injection matching placebo, administered once. Receives: Drug: AP026 (TQA2226) for injection matching placebo |
| AP026 (TQA2226) for injection Multiple administration dose (MAD) | Experimental | AP026 (TQA2226) for injection, administered 4 times. Receives: Drug: AP026 (TQA2226) for injection |
| AP026 (TQA2226) for injection matching placebo Multiple administration dose (MAD) | Placebo comparator | AP026 (TQA2226) for injection matching placebo, administered 4 times. Receives: Drug: AP026 (TQA2226) for injection matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Incidence of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Measured: From patient enrollment to withdrawal, estimated up to 2 months.
Severity of adverse events
Severity of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Measured: From patient enrollment to withdrawal, estimated up to 2 months.
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Measured: From patient enrollment to withdrawal, estimated up to 2 months.
Severity of serious adverse events (SAEs)
Severity of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Measured: From patient enrollment to withdrawal, estimated up to 2 months.
Secondary outcomes (14)
Peak concentration (Cmax)
The highest blood drug concentration achieved after administration.
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Plasma concentration-area under time curve (AUC0-t)
The area under the plasma concentration-time curve from the beginning of the first administration to the last measurable concentration point.
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Plasma concentration-area under time curve (AUC0-∞)
Extrapolated from the first administration to the area under the plasma concentration-time curve to infinity.
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Peak Time (Tmax)
the time required to reach the highest concentration (peak drug concentration).
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Apparent volume of distribution (Vd/F)
The theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Clearance (CL)
The volume of a substance in plasma that the body or organ can clear per unit time.
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Elimination half-life time (t1/2)
The time it takes to reduce the concentration of drugs in the blood by half.
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Tmax, ss
Time required to reach steady-state peak concentration after administration
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Cmax, ss
The highest blood drug concentration that occurs after reaching steady state
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Cmin, ss
The lowest blood drug concentration that occurs after reaching steady state
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
AUC, ss
The area under the plasma concentration-time curve of the steady state
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Rac
The ratio of steady-state blood drug concentration to blood drug concentration after the first administration
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Anti-Drug Antibody (ADA)
The incidence of ADA after drug administration for evaluating the immunogenicity of antibody drugs.
Measured: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start24 May 2023
- Primary completion26 Jul 2023
- Study completion16 Mar 2026
Why it stopped: Study terminated for strategic business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143423
- Sponsor's protocol ID
- TQA2226-I-01
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Apr 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate AP026 (TQA2226) for Injection in Adult Subjects After Single/Multiple Administration.
- ClinicalTrials.gov ID
- NCT06143423
- Acronym / sponsor ID
- TQA2226-I-01
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated for strategic business reasons.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 22 Nov 2023 (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.
This study was a randomized, double-blind, placebo-controlled phase I clinical trial of AP026 (TQA2226) for injection in adult healthy subjects, which planned to recruit 74 healthy subjects. The main purpose was to evaluate the safety and tolerance of AP026 (TQA2226) for injection after single and multiple doses in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AP026 (TQA2226) for injection Single administration dose (SAD) | Experimental | Drug: AP026 (TQA2226) for injectionAP026 (TQA2226) for injection, administered once. |
| AP026 (TQA2226) for injection matching placebo Single administration dose (SAD) | Placebo comparator | Drug: AP026 (TQA2226) for injection matching placeboAP026 (TQA2226) for injection matching placebo, administered once. |
| AP026 (TQA2226) for injection Multiple administration dose (MAD) | Experimental | Drug: AP026 (TQA2226) for injectionAP026 (TQA2226) for injection, administered 4 times. |
| AP026 (TQA2226) for injection matching placebo Multiple administration dose (MAD) | Placebo comparator | Drug: AP026 (TQA2226) for injection matching placeboAP026 (TQA2226) for injection matching placebo, administered 4 times. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign an informed consent form before the study and have a thorough understanding of the content, process, and potential adverse reactions of the study;
- Able to complete the study according to the requirements of the protocol;
- Subjects (including their partners) are willing to voluntarily take effective contraceptive measures within 6 months after the last study drug administration;
- Male and female subjects aged 18-55 (inclusive);
- Male subjects weighing no less than 50 kilograms and female subjects weighing no less than 45 kilograms, With a body mass index within the range of 18~28kg/m2 (inclusive);
Key exclusion criteria (23 listed)
- Pregnant and lactating women;
- There are abnormal and clinically significant clinical laboratory examination results, or clinically significant diseases within 12 months before screening, which is not recommended to participate in the trial after evaluation by the investigators. Subjects with a previous medical history but are recovered with clinical evidence can be included in this study;
- During the screening period, any one of the vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, and other auxiliary examination results is abnormal and judged by the investigator to have clinical significance;
- Subjects who test positive for any of the hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (Anti HCV), human immunodeficiency virus antibody (Anti HIV), and Treponema pallidum antibody (Anti TP);
- Those who have undergone surgery within 4 weeks before screening or plan to undergo surgery during the study period;
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 |
|---|---|---|
| AP026 (TQA2226) for injectionAP026 (TQA2226) for injection is a GLP-1-FGF21-Fc bifunctional fusion protein. | Drug | AP026 (TQA2226) for injection Multiple administration dose (MAD), AP026 (TQA2226) for injection Single administration dose (SAD) |
| AP026 (TQA2226) for injection matching placeboAP026 (TQA2226) for injection matching placebo is a placebo produced according to AP026 (TQA2226) for injection, and has no effect on GLP-1 and FGF21. | Drug | AP026 (TQA2226) for injection matching placebo Multiple administration dose (MAD), AP026 (TQA2226) for injection matching placebo Single administration dose (SAD) |
Primary outcome
Incidence of adverse events (AEs)
Time frame: From patient enrollment to withdrawal, estimated up to 2 months.
Incidence of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Severity of adverse events
Time frame: From patient enrollment to withdrawal, estimated up to 2 months.
Severity of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Incidence of serious adverse events (SAEs)
Time frame: From patient enrollment to withdrawal, estimated up to 2 months.
Incidence of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Severity of serious adverse events (SAEs)
Time frame: From patient enrollment to withdrawal, estimated up to 2 months.
Severity of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
14 secondary outcomes
Peak concentration (Cmax)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Plasma concentration-area under time curve (AUC0-t)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Plasma concentration-area under time curve (AUC0-∞)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Peak Time (Tmax)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Apparent volume of distribution (Vd/F)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Clearance (CL)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Elimination half-life time (t1/2)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Plasma concentration at steady state (Cav, SS)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Tmax, ss
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Cmax, ss
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Cmin, ss
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
AUC, ss
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Rac
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Anti-Drug Antibody (ADA)
Time frame: SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.
Results and safety
The study was stopped early (reason given: Study terminated for strategic business reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 AP026 (TQA2226) for injection in people with Diabetes Mellitus, Type 2, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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 6 inclusion and 23 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: stopped early, as of the sponsor's last update on 22 Apr 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?
The study was stopped early (reason given: Study terminated for strategic business reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: From patient enrollment to withdrawal, estimated up to 2 months.). The study lists 4 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 22 Apr 2026.