Phase
Condition
Lupus
Cutaneous Lupus Erythematosus
Musculoskeletal Diseases
Treatment
TQB3702 placebo
TQB3702 tablets
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy participants are aged between 18 and 55 years old (including 18 and 55 yearsold), 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 awritten informed consent form;
Subjects (including partners) are willing to self screen and voluntarily takeappropriate and effective contraceptive measures (non contraceptive pills) within 6months after the last study drug administration.
Exclusion
Exclusion Criteria:
Pregnant and lactating women.
Previous or current history of heart, endocrine, metabolic, kidney, liver,gastrointestinal, skin, infection, blood, neurological, or psychiatricdiseases/abnormalities, or related chronic or acute diseases, the researcherassessed that it is not suitable to participate in the trial.
Screening period vital signs, physical examination, laboratory examination, 15 leadelectrocardiogram, chest anteroposterior lateral X-ray, abdominal ultrasound, femalesubjects also need to undergo uterine and bilateral accessory ultrasound, withabnormal 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 ofuntreated active tuberculosis patients, or laboratory test T-SPOT.TB (a type ofEnzyme-Linked Immunospot Assay) test positive individuals.
Suffering from a history of severe bacterial, fungal, or viral infections within thefirst two months of randomization, requiring hospitalization and treatment withintravenous antibiotics or antiviral drugs.
Randomly receive live vaccine within the first 4 weeks or plan to receive livevaccine during the study period.
During the screening period, clinically significant infections may occur, includingbut not limited to upper respiratory tract infections, lower respiratory tractinfections, urinary tract infections, etc., and require antibiotic or antiviraltreatment.
A history of severe herpes zoster or herpes simplex infection, including but notlimited to herpes simplex encephalitis, disseminated herpes simplex, and generalizedherpes zoster.
Use any systemic cytotoxicity or systemic immunosuppressive drugs within the first 6months of randomization or during the study period, or use any local cytotoxicity orlocal immunosuppressive drugs within the first 4 weeks of randomization or 5half-lives or during the study period.
Any other biological agents that have been marketed or studied within the firstthree months or five half-lives of randomization.
Individuals who have undergone surgery within the first 4 weeks of randomization orplan to undergo surgery during the study period.
Individuals who have lost blood or donated more than 400 mL of blood within thefirst 4 weeks of randomization.
Individuals who have experienced external injuries within the first 6 months ofrandomization, such as car accidents, fractures, etc.
Within the first 4 weeks of randomization, any prescription, over-the-counter, orherbal medication was taken, except for vitamin products.
Potential difficulty in blood collection, with a history of fainting from needlesand blood.
Allergy to any known ingredients of TQB3702, or any history of severe drugallergies.
Individuals with a history of drug abuse or positive urine drug screening.
Smoking more than 5 cigarettes per day or using an equivalent amount of nicotine ornicotine containing products within the first 3 months of randomization, or notstopping the use of any tobacco products during the trial period.
Individuals who have long-term alcohol abuse or have consumed more than 14 units ofalcohol per week within the first 3 months of screening, or have been unable toabstain from alcohol during the trial period, or have tested positive for alcoholbreath.
Any other reasonable medical, mental, or social reasons that the researcher believescannot participate in this study.
Study Design
Connect with a study center
Guangdong provincial people's hospital
Guangzhou, Guangdong 519041
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.