Systemic Lupus ErythematosusPhase 1NCT06448273
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic of TQB3702 Tablets in Healthy Adult Subjects
A Phase 1 study testing TQB3702 tablets in people with Systemic Lupus Erythematosus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- TQB3702 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2024to Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong provincial people's hospital
Guangzhou, Guangdong, 519041
Shilong Zhong, 18620829696, gdph_zhongsl@gd.gov.cn
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic Characteristics of Single and Multiple Doses of TQB3702 Tablets in Healthy Adult Subjects
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
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- TQB3702 tablets, TQB3702 placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3702 tabletsDrug
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.
TQB3702 placeboDrug
TQB3702 placebo contains no active substance.
| Study group | Role | What they receive |
|---|---|---|
| TQB3702 tablets | Experimental | TQB3702 tables is administered as a single dose or multiple dose. Receives: Drug: TQB3702 tablets |
| TQB3702 placebo | Placebo comparator | TQB3702 placebo is administered as a single dose or multiple dose. Receives: Drug: TQB3702 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 17 days
Abnormal laboratory test indicators
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Measured: 17 days
Secondary outcomes (3)
Time to reach maximum observed plasma concentration (Tmax)
Time to reach maximum (peak) plasma concentration following drug administration.
Measured: 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)
The Cmax is the maximum observed plasma concentration of TQB3702.
Measured: 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)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start19 Jul 2024
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448273
- Sponsor's protocol ID
- TQB3702-I-02
- Status last verified
- Apr 2024
- First submitted
- 4 Jun 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetic Characteristics of Single and Multiple Doses of TQB3702 Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06448273
- Acronym / sponsor ID
- TQB3702-I-02
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB3702 tablets | Experimental | Drug: TQB3702 tabletsTQB3702 tables is administered as a single dose or multiple dose. |
| TQB3702 placebo | Placebo comparator | Drug: TQB3702 placeboTQB3702 placebo is administered as a single dose or multiple dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3702 tabletsTQB3702 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. | Drug | TQB3702 tablets |
| TQB3702 placeboTQB3702 placebo contains no active substance. | Drug | TQB3702 placebo |
Primary outcome
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.
3 secondary outcomes
Time to reach maximum observed plasma concentration (Tmax)
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
Maximum Plasma Concentration (Cmax)
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
Elimination half-life (t1/2)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB3702 tablets in people with Systemic Lupus Erythematosus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shilong Zhong, Doctor (18620829696, gdph_zhongsl@gd.gov.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events rate (time frame: 17 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.