A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic of TQB3702 Tablets in Healthy Adult Subjects

Last updated: August 8, 2024
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Lupus

Cutaneous Lupus Erythematosus

Musculoskeletal Diseases

Treatment

TQB3702 placebo

TQB3702 tablets

Clinical Study ID

NCT06448273
TQB3702-I-02
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: TQB3702 placebo
Phase: 1
Study Start date:
July 19, 2024
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Guangdong provincial people's hospital

    Guangzhou, Guangdong 519041
    China

    Active - Recruiting

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