CClinicalTrials.gg
RecruitingNCT06448273Updated Aug 12, 2024

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

A Phase 1 interventional study of TQB3702 tablets and TQB3702 placebo in Systemic Lupus Erythematosus, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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

02

Conditions studied

  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
  • Any other biological agents that have been marketed or studied within the first three months or five half-lives of randomization.
  • Individuals who have undergone surgery within the first 4 weeks of randomization or plan to undergo surgery during the study period.
  • Individuals who have lost blood or donated more than 400 mL of blood within the first 4 weeks of randomization.
  • Individuals who have experienced external injuries within the first 6 months of randomization, such as car accidents, fractures, etc.
  • Within the first 4 weeks of randomization, any prescription, over-the-counter, or herbal medication was taken, except for vitamin products.
  • Potential difficulty in blood collection, with a history of fainting from needles and blood.
  • Allergy to any known ingredients of TQB3702, or any history of severe drug allergies.
  • 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 or nicotine containing products within the first 3 months of randomization, or not stopping the use of any tobacco products during the trial period.
  • Individuals who have long-term alcohol abuse or have consumed more than 14 units of alcohol per week within the first 3 months of screening, or have been unable to abstain from alcohol during the trial period, or have tested positive for alcohol breath.
  • Any other reasonable medical, mental, or social reasons that the researcher believes cannot participate in this study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    TQB3702 tablets

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

    Drug: TQB3702 tablets

  • Placebo comparator
    TQB3702 placebo

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

    Drug: TQB3702 placebo

Interventions

  • DrugTQB3702 tablets

    TQB3702 tablets is administered as a single dose on day 1, or once daily on Days 1 to 7 on multiple dose. Dosage: 100mg, 150/200mg.

  • DrugTQB3702 placebo

    TQB3702 placebo contains no active substance.

06

What researchers measure

Primary outcomes

  1. Adverse events rate

    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).

    Time frame: 17 days

  2. Abnormal laboratory test indicators

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

    Time frame: 17 days

Secondary outcomes

  1. Time to reach maximum observed plasma concentration (Tmax)

    Time to reach maximum (peak) plasma concentration following drug administration.

    Time frame: 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

  2. Maximum Plasma Concentration (Cmax)

    The Cmax is the maximum observed plasma concentration of TQB3702.

    Time frame: 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

  3. Elimination half-life (t1/2)

    Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

    Time frame: 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

07

Study locations

1 of 1 sites recruiting
  • Guangdong provincial people's hospital
    Guangzhou, Guangdong 519041, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06448273
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Jun 7, 2024
Start date
Jul 19, 2024
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Aug 12, 2024

Study contacts

Shilong Zhong, Doctor
Contact
gdph_zhongsl@gd.gov.cn
18620829696

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion