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

Last updated: November 16, 2023
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus, Type 2

Treatment

AP026 (TQA2226) for injection matching placebo

AP026 (TQA2226) for injection

Clinical Study ID

NCT06143423
TQA2226-I-01
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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. The main purpose was to evaluate the safety and tolerance of AP026 (TQA2226) for injection after single and multiple doses in healthy subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sign an informed consent form before the study and have a thorough understanding ofthe 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 effectivecontraceptive 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 lessthan 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 clinicalsignificance (judged by the investigators).

Exclusion

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 notrecommended to participate in the trial after evaluation by the investigators.Subjects with a previous medical history but are recovered with clinical evidence canbe included in this study;
  • During the screening period, any one of the vital signs, physical examination,laboratory examination, 12 lead electrocardiogram, and other auxiliary examinationresults 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 (AntiHIV), and Treponema pallidum antibody (Anti TP);
  • Those who have undergone surgery within 4 weeks before screening or plan to undergosurgery during the study period;
  • Received investigational drugs or participated in clinical trials within 3 monthsprior to screening;
  • Received immunoglobulin or blood products within 30 days before randomization;
  • Donated blood (> 300 mL) or experienced significant blood loss (> 400 mL) within 3months prior to screening;
  • Subjects with a history of needle sickness, blood sickness, or potential difficult incollecting blood;
  • History of allergic reactions to other therapeutic monoclonal antibodies or biologicalagents, or history of allergies to multiple drugs or foods, especially to ingredientssimilar to the study drug;
  • Smoking more than 5 cigarettes per day or using an equivalent amount of nicotine ornicotine containing products within 3 months before randomization, or failing to stopusing any tobacco products during the trial period;
  • Those who have been drinking excessively for a long time or have consumed more than 14units of alcohol per week within 3 months before screening, or cannot abstain fromalcohol 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 4months 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 anytopical drugs of the above forms at the injection site of this study;
  • From the screening period to the study medication, acute diseases or concomitantmedication occured.
  • Any medical history that may affect drug absorption, distribution, metabolism, andexcretion.
  • Any situation that the investigator believes will pose a safety risk to the subjectduring the study or may interfere with the implementation of this study, or theinvestigator believes that the subject may not be able to complete this study or maynot be able to comply with the requirements of this study.
  • QT interval > 450 milliseconds, or electrocardiogram is not suitable forConcentration-QT measurement (according to the judgment of the investigator).
  • History of risk factors for torsade de pointe ventricular tachycardia. Subject with afamily 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.

Study Design

Total Participants: 74
Treatment Group(s): 2
Primary Treatment: AP026 (TQA2226) for injection matching placebo
Phase: 1
Study Start date:
May 24, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • The first hospital of Jilin University

    Changchun, Jilin 130061
    China

    Active - Recruiting

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