Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic Characteristics of Single and Multiple Doses of TQB3702 Tablets in Healthy Adult Subjects

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country40 target enrollmentJuly 19, 2024

ConditionsSystemic Lupus Erythematosus

InterventionsTQB3702 tablets TQB3702 placebo

Overview

Phase: Phase 1
Intervention: TQB3702 tablets
Conditions: Systemic Lupus Erythematosus
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 40
Locations: 1
Primary Endpoint: Adverse events rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, randomized, double-blind, placebo-controlled, dose-escalating clinical study aimed at evaluating the safety of TQB3702 tablets following single and multiple doses administered to healthy subjects

Registry

clinicaltrials.gov

Start Date

July 19, 2024

End Date

October 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy participants are aged between 18 and 55 years old (including 18 and 55 years old), regardless of gender;
•Male weight ≥50kg, female weight ≥45kg, with a body mass index (BMI) between 19 and 26 kg/m2;
•Fully understand this study, voluntarily participate in the trial, and have signed a written informed consent form;
•Subjects (including partners) are willing to self screen and voluntarily take appropriate and effective contraceptive measures (non contraceptive pills) within 6 months after the last study drug administration.

Exclusion Criteria

•Pregnant and lactating women.
•Previous or current history of heart, endocrine, metabolic, kidney, liver, gastrointestinal, skin, infection, blood, neurological, or psychiatric diseases/abnormalities, or related chronic or acute diseases, the researcher assessed that it is not suitable to participate in the trial.
•Screening period vital signs, physical examination, laboratory examination, 15 lead electrocardiogram, chest anteroposterior lateral X-ray, abdominal ultrasound, female subjects also need to undergo uterine and bilateral accessory ultrasound, with abnormal and clinically significant results.
•There are serum virological abnormalities during the screening period;
•Active tuberculosis exists in the screening period, or is a close family contact of untreated active tuberculosis patients, or laboratory test T-SPOT.TB (a type of Enzyme-Linked Immunospot Assay) test positive individuals.
•Suffering from a history of severe bacterial, fungal, or viral infections within the first two months of randomization, requiring hospitalization and treatment with intravenous antibiotics or antiviral drugs.
•Randomly receive live vaccine within the first 4 weeks or plan to receive live vaccine during the study period.
•During the screening period, clinically significant infections may occur, including but not limited to upper respiratory tract infections, lower respiratory tract infections, urinary tract infections, etc., and require antibiotic or antiviral treatment.
•A history of severe herpes zoster or herpes simplex infection, including but not limited to herpes simplex encephalitis, disseminated herpes simplex, and generalized herpes zoster.
•Use any systemic cytotoxicity or systemic immunosuppressive drugs within the first 6 months of randomization or during the study period, or use any local cytotoxicity or local immunosuppressive drugs within the first 4 weeks of randomization or 5 half-lives or during the study period.

Arms & Interventions

TQB3702 tablets

TQB3702 tables is administered as a single dose or multiple dose.

Intervention: TQB3702 tablets

TQB3702 placebo

TQB3702 placebo is administered as a single dose or multiple dose.

Intervention: TQB3702 placebo

Outcomes

Primary Outcomes

Adverse events rate

Time Frame: 17 days

Number of subjects with adverse events (AEs) and serious adverse events (SAEs), the evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0).

Abnormal laboratory test indicators

Time Frame: 17 days

Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

Secondary Outcomes

Time to reach maximum observed plasma concentration (Tmax)(1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose)
Elimination half-life (t1/2)(1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose)
Maximum Plasma Concentration (Cmax)(1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose)