TerminatedPhase 1

A Clinical Trial of AP026 (TQA2226) for Injection in Adult Subjects.

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate AP026 (TQA2226) for Injection in Adult Subjects After Single/Multiple Administration.

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Asset

AP026 / TQA2226

GLP-1 / FGF21 dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoints

•Adverse events (AEs)•Severity of adverse events•Serious adverse events (SAEs)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06143423

Org study IDTQA2226-I-01

Timeline

Milestones

Study start2023-05-24actual

Primary completion2023-07-26actual

Study first posted2023-11-22actual

Study completion2026-03-16actual

Last update posted2026-04-22actual

Assets

Investigational agents

AP026 / TQA2226

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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).

Exclusion criteria

•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;

•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.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

16 endpoints

Primary/protocol endpoint

Incidence of adverse events (AEs)

Time frame:From patient enrollment to withdrawal, estimated up to 2 months.

event count, event

Primary/protocol endpoint

Severity of adverse events

Time frame:From patient enrollment to withdrawal, estimated up to 2 months.

descriptive

Primary/protocol endpoint

Incidence of serious adverse events (SAEs)

Time frame:From patient enrollment to withdrawal, estimated up to 2 months.

event count, event

Primary/protocol endpoint

Severity of serious adverse events (SAEs)

Time frame:From patient enrollment to withdrawal, estimated up to 2 months.

descriptive

Secondary/protocol endpoint

Peak concentration (Cmax)