A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TQC2938 Injection in Healthy Adult Subjects After Single and Multiple Administration

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.1 site in 1 country84 target enrollmentJune 13, 2023

ConditionsAsthma

InterventionsTQC2938 Injection TQC2938 Placebo

DrugsTQC2938 Injection TQC2938 Placebo

Overview

Phase: Phase 1
Intervention: TQC2938 Injection
Conditions: Asthma
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Enrollment: 84
Locations: 1
Primary Endpoint: Adverse events (AEs)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of TQC2938 injection in healthy adults.

Registry

clinicaltrials.gov

Start Date

June 13, 2023

End Date

November 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sign informed consent before the study to fully understand the purpose, process and possible adverse reactions of the test.
•Adults aged between 18 and 60 years (inclusive)，both male and female;
•The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 18\~28 kg/m2 (inclusive);
•The subjects were able to communicate well with the investigators, voluntarily and were able to understand and follow the protocol to complete the study;
•Female patient had no plans to become pregnant for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age。

Exclusion Criteria

•Pregnant or lactating women;
•Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
•People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG) and Chest radiograph during screening period;
•Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP);
•A history of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), occurred within 30 days prior to and during screening and required antibiotic or antiviral treatment;
•Had undergone surgery within 8 weeks prior to screening period or expected to undergo surgery during the study period;
•Participated in any clinical trial within 3 months prior to the screening period;
•Received immunoglobulins or blood products within 30 days prior to randomization;
•Blood donation or significant blood loss of more than 400 mL within 3 months prior to randomization, or plan to donate blood within 3 months;
•Potential blood collection difficulties, can not tolerate venipuncture or have a history of fainting needles and fainting blood;