AsthmaPhase 1NCT06449859
A Clinical Trial of TQC2938 Injection in Healthy Adult Subjects
A Phase 1 study testing TQC2938 Injection in people with Asthma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of TQC2938 injection in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- TQC2938 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2023to Nov 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign informed consent before the study to fully understand the purpose, process and possible adverse reactions of the test.
- Adults aged between 18 and 60 years (inclusive)，both male and female;
- The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 18~28 kg/m2 (inclusive);
- The subjects were able to communicate well with the investigators, voluntarily and were able to understand and follow the protocol to complete the study;
- Female patient had no plans to become pregnant for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age。
Who cannot join
- Pregnant or lactating women;
- Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
- People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG) and Chest radiograph during screening period;
- Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP);
- A history of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), occurred within 30 days prior to and during screening and required antibiotic or antiviral treatment;
- Had undergone surgery within 8 weeks prior to screening period or expected to undergo surgery during the study period;
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- Participated in any clinical trial within 3 months prior to the screening period;
- Received immunoglobulins or blood products within 30 days prior to randomization;
- Blood donation or significant blood loss of more than 400 mL within 3 months prior to randomization, or plan to donate blood within 3 months;
- Potential blood collection difficulties, can not tolerate venipuncture or have a history of fainting needles and fainting blood;
- A history of allergic reaction to treatment with another therapeutic monoclonal antibody or biologics, a history of any well-defined drug or food allergy, especially to ingredients similar to the drug in this trial;
- Those who received or planned to receive inactivated or active vaccines within 30 days prior to randomization or throughout the study period, including the follow-up period；
- Those who smoked more than 5 cigarettes/day or used a comparable amount of nicotine or nicotine-containing products in the 6 months prior to randomization, or could not stop using any tobacco products during the trial period；
- People with chronic alcohol abuse or who drank more than 14 units of alcohol per week in the 3 months prior to screening (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or who could not abstain during the test period, or who tested positive for alcohol breath；
- History of drug abuse or a positive result of urine drug test at screening;
- Received any marketed or investigational biological agent (other than vaccines) within 4 months or 5 half-lives (whichever is older) prior to randomization；
- Any prescription, over-the-counter, and herbal medicines, except vitamin products, were taken in the 4 weeks prior to randomization；
- Use of any systemic cytotoxicity or systemic immunosuppressants within 6 months prior to randomization or during the study period, or any local cytotoxin or local immunosuppressive drug within 30 days or 5 half-life periods (whichever is longer) prior to randomization or during the study period；
- Any situation in which the investigator believes that this poses a safety risk to the subject in the trial or may interfere with the conduct of the study, or that the investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TQC2938 Injection in Healthy Adult Subjects After Single and Multiple Administration
The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of TQC2938 injection in healthy adults.
- Conditions
- Asthma
- Being tested
- TQC2938 Injection, TQC2938 Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC2938 InjectionDrug
TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
TQC2938 PlaceboDrug
TQC2938 Placebo is a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| TQC2938 Injection (52.5mg/0.35ml) | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous (SC) injection. Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (210mg/1.4ml)-subcutaneous injection | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous injection. Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (210mg/1.4ml)-intravenous injection | Experimental | TQC2938 Injection is administered as a single dose of intravenous (IV) injection . Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (420mg/2.8ml) | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous injection. Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (840mg/5.6ml)-subcutaneous injection | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous injection. Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (1260mg/8.4ml) | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous injection. Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (210mg/1.4ml)-subcutaneous injection-multiple doses | Experimental | TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (840mg/5.6ml)-subcutaneous injection-multiple doses | Experimental | TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. Receives: Drug: TQC2938 Injection |
| TQC2938 Injection (630mg/4.2ml) | Experimental | TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. Receives: Drug: TQC2938 Injection |
| TQC2938 Placebo | Placebo comparator | TQC2938 Placebo is administered as a single dose or multiple doses, once every 28 days, three times in total. Receives: Drug: TQC2938 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
The occurrence of all adverse events (AEs).
Measured: Single dose: Up to Day 113. Multiple doses: Up to Day 169
Serious adverse events (SAEs)
The occurrence and incidence of all serious adverse events (SAEs).
Measured: Single dose: Up to Day 113. Multiple doses: Up to Day 169
Clinical laboratory abnormalities
Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram, etc.
Measured: Single dose: Up to Day 113. Multiple doses: Up to Day 169
Secondary outcomes (24)
Maximum serum concentration (Cmax) of subcutaneous injection for single dose
The Cmax is the maximum observed serum concentration of study drug.
Measured: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Maximum serum concentration (Cmax) of intravenous injection for single dose
The Cmax is the maximum observed serum concentration of study drug.
Measured: Single dose: pre-dose (-1 to 0 hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Maximum serum concentration (Cmax) of subcutaneous injection for multiple doses
The Cmax is the maximum observed serum concentration of study drug.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose on multiple dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for single dose
Time to reach maximum (peak) serum concentration following drug administration.
Measured: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Time to reach maximum observed serum concentration (Tmax) of intravenous injection for single dose
Time to reach maximum (peak) serum concentration following drug administration.
Measured: Single dose: pre-dose (-1 to 0hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for multiple doses
Time to reach maximum (peak) serum concentration following drug administration.
Measured: Multiple doses: pre-dose (-1 to 0hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504hours post-dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Minimum concentration of drug in serum at steady state (Cmin, ss) of subcutaneous injection for multiple doses
Cmin,ss is the minimum serum concentration at steady state.
Measured: Multiple doses: Pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of subcutaneous injection for single dose
Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.
Measured: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of intravenous injection for single dose
Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.
Measured: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of of subcutaneous injection for multiple dose
Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.
Measured: Multiple doses: pre-dose(-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Maximum concentration of drug in serum at steady state (Cmax, ss) of subcutaneous injection for multiple doses
Cmax, ss is the peak serum concentration of TQC2938 Injection during dosing interval at steady state.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Time to maximum serum concentration at steady state (Tmax, ss) of subcutaneous injection
Tmax,ss is defined as time to reach the peak serum concentration at steady state for TQC2938 Injection.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Area under curve of steady state (AUCss) of subcutaneous injection
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of TQC2938 Injection in serum.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Half-life (t1/2) of subcutaneous injection for single dose
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Half-life (t1/2) of intravenous injection for single dose
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Half-life (t1/2) of intravenous injection for multiple dose
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Apparent volume of distribution (Vd/F) of subcutaneous injection for single dose
Apparent volume of distribution of the TQC2938 Injection in serum.
Measured: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Apparent volume of distribution (Vd/F) of intravenous injection for single dose
Apparent volume of distribution of the TQC2938 Injection in serum.
Measured: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Apparent volume of distribution (Vd/F) of subcutaneous injection for multiple dose
Apparent volume of distribution of the TQC2938 Injection in serum.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Apparent clearance (CL/F) of subcutaneous injection for single dose
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Apparent clearance (CL/F) of intravenous injection for single dose
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Apparent clearance (CL/F) of subcutaneous injection for multiple dose
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Accumulation ratio (Rac) of subcutaneous injection for multiple dose
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of TQC2938 Injection in serum.
Measured: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Anti-drug antibodies (ADA)
Incidence of ADA, a participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Measured: Single dose: (-1 to 0 hour) (pre-dose), 672, 1344, 2016 and 2688 hours postdose. Multiple doses: (-1 to 0 hour) before the first,second and third administration, 1344 and 2688 hours after intravenous injection of Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start13 Jun 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449859
- Sponsor's protocol ID
- TQC2938-I-01
- Status last verified
- Jan 2024
- First submitted
- 3 Jun 2024
- Last updated
- 10 Jun 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TQC2938 Injection in Healthy Adult Subjects After Single and Multiple Administration
- ClinicalTrials.gov ID
- NCT06449859
- Acronym / sponsor ID
- TQC2938-I-01
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 10 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.
The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of TQC2938 injection in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| TQC2938 Injection (52.5mg/0.35ml) | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a single dose of subcutaneous (SC) injection. |
| TQC2938 Injection (210mg/1.4ml)-subcutaneous injection | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a single dose of subcutaneous injection. |
| TQC2938 Injection (210mg/1.4ml)-intravenous injection | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a single dose of intravenous (IV) injection . |
| TQC2938 Injection (420mg/2.8ml) | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a single dose of subcutaneous injection. |
| TQC2938 Injection (840mg/5.6ml)-subcutaneous injection | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a single dose of subcutaneous injection. |
| TQC2938 Injection (1260mg/8.4ml) | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a single dose of subcutaneous injection. |
| TQC2938 Injection (210mg/1.4ml)-subcutaneous injection-multiple doses | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. |
| TQC2938 Injection (840mg/5.6ml)-subcutaneous injection-multiple doses | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. |
| TQC2938 Injection (630mg/4.2ml) | Experimental | Drug: TQC2938 InjectionTQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. |
| TQC2938 Placebo | Placebo comparator | Drug: TQC2938 PlaceboTQC2938 Placebo is administered as a single dose or multiple doses, once every 28 days, three times in total. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sign informed consent before the study to fully understand the purpose, process and possible adverse reactions of the test.
- Adults aged between 18 and 60 years (inclusive)，both male and female;
- The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 18~28 kg/m2 (inclusive);
- The subjects were able to communicate well with the investigators, voluntarily and were able to understand and follow the protocol to complete the study;
- Female patient had no plans to become pregnant for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age。
Key exclusion criteria (19 listed)
- Pregnant or lactating women;
- Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
- People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG) and Chest radiograph during screening period;
- Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP);
- A history of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), occurred within 30 days prior to and during screening and required antibiotic or antiviral treatment;
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 |
|---|---|---|
| TQC2938 InjectionTQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade. | Drug | TQC2938 Injection (1260mg/8.4ml), TQC2938 Injection (210mg/1.4ml)-intravenous injection, TQC2938 Injection (210mg/1.4ml)-subcutaneous injection, TQC2938 Injection (210mg/1.4ml)-subcutaneous injection-multiple doses, TQC2938 Injection (420mg/2.8ml), TQC2938 Injection (52.5mg/0.35ml), TQC2938 Injection (630mg/4.2ml), TQC2938 Injection (840mg/5.6ml)-subcutaneous injection, TQC2938 Injection (840mg/5.6ml)-subcutaneous injection-multiple doses |
| TQC2938 PlaceboTQC2938 Placebo is a placebo comparator | Drug | TQC2938 Placebo |
Primary outcome
Adverse events (AEs)
Time frame: Single dose: Up to Day 113. Multiple doses: Up to Day 169
The occurrence of all adverse events (AEs).
Serious adverse events (SAEs)
Time frame: Single dose: Up to Day 113. Multiple doses: Up to Day 169
The occurrence and incidence of all serious adverse events (SAEs).
Clinical laboratory abnormalities
Time frame: Single dose: Up to Day 113. Multiple doses: Up to Day 169
Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram, etc.
24 secondary outcomes
Maximum serum concentration (Cmax) of subcutaneous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Maximum serum concentration (Cmax) of intravenous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Maximum serum concentration (Cmax) of subcutaneous injection for multiple doses
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose on multiple dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Time to reach maximum observed serum concentration (Tmax) of intravenous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for multiple doses
Time frame: Multiple doses: pre-dose (-1 to 0hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504hours post-dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Minimum concentration of drug in serum at steady state (Cmin, ss) of subcutaneous injection for multiple doses
Time frame: Multiple doses: Pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of subcutaneous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of intravenous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of of subcutaneous injection for multiple dose
Time frame: Multiple doses: pre-dose(-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Maximum concentration of drug in serum at steady state (Cmax, ss) of subcutaneous injection for multiple doses
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Time to maximum serum concentration at steady state (Tmax, ss) of subcutaneous injection
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Area under curve of steady state (AUCss) of subcutaneous injection
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Half-life (t1/2) of subcutaneous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Half-life (t1/2) of intravenous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Half-life (t1/2) of intravenous injection for multiple dose
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Apparent volume of distribution (Vd/F) of subcutaneous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Apparent volume of distribution (Vd/F) of intravenous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Apparent volume of distribution (Vd/F) of subcutaneous injection for multiple dose
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Apparent clearance (CL/F) of subcutaneous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Apparent clearance (CL/F) of intravenous injection for single dose
Time frame: Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Apparent clearance (CL/F) of subcutaneous injection for multiple dose
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Accumulation ratio (Rac) of subcutaneous injection for multiple dose
Time frame: Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Anti-drug antibodies (ADA)
Time frame: Single dose: (-1 to 0 hour) (pre-dose), 672, 1344, 2016 and 2688 hours postdose. Multiple doses: (-1 to 0 hour) before the first,second and third administration, 1344 and 2688 hours after intravenous injection of Day 57
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 TQC2938 Injection in people with Asthma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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 5 inclusion and 19 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 10 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Single dose: Up to Day 113. Multiple doses: Up to Day 169). The study lists 3 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 10 Jun 2024.