Asthma Severe Persistent ControlledPhase 1NCT04923607
Phase I Clinical Trial of TQC2731 Injection
A Phase 1 study testing TQC2731 in people with Asthma Severe Persistent Controlled, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is the first-in-human phase 1 trial of TQC2731 injection in healthy subjects and in patients with severe asthma to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma Severe Persistent Controlled
- What is being tested?
- TQC2731
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2021to 25 Aug 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects:Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions.
- Healthy subjects:Aged between 18 and 60 years old, both men and women;
- Healthy subjects:Female ≥45kg, male ≥50kg, body mass index (BMI) is 18-28 kg/m^2 (including the critical value), BMI=weight (kg)/height^2 (m^2);
- Asthma subjects:Aged between 18 and 70 years old, both men and women;
- Asthma subjects:Female ≥45kg, male ≥50kg;
- Asthma subjects:according to the GINA guidelines (GINA 2020), subjects who received middle, or high-dose ICS in asthma control drugs prescribed by the doctor at least 6 months prior to Visit 1;
Who cannot join
- Healthy subjects: Pregnant and lactating women;
- Healthy subjects:preexisting or existing heart, endocrine, metabolism, kidney, liver, gastrointestinal, skin, infection, blood, nerve, mental diseases or abnormalities, or related chronic or acute diseases, the investigator assesses that it is not appropriate to participate in the trial;
- Healthy subjects:Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, and chest radiograph during the screening period are abnormal and have clinical significance;
- Healthy subjects:Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) and Treponema pallidum antibody (Anti-TP), any of the above positive subjects;
- Healthy subjects:A history of clinically significant infections before and during screening, including upper respiratory tract infection (URTI) and lower respiratory tract infection (LRTI), and requires antibiotic or antiviral treatment;
- Healthy subjects:Those who have undergone surgery within 4 weeks before screening, or plan to undergo surgery during the study period;
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- Asthma subjects: Pregnant and lactating women;
- Asthma subjects:Patients with abnormal vital signs, physical examination, 12-lead electrocardiogram results and clinical significance during the screening period;
- Asthma subjects:preexisting or existing heart, endocrine, metabolism, kidney, liver, gastrointestinal, skin, infection, blood, nerve, or mental illness, etc., or related chronic or acute diseases, the investigator's assessment should not participate in the trial; (except for the target disease)
- Asthma subjects:Accompanied by clinically major lung diseases other than asthma (for example, active lung infection, non-asthmatic chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity-related Hypoventilation syndrome, lung cancer, α1 antitrypsin deficiency, and primary ciliary dyskinesia) or accompanied by pulmonary or systemic diseases other than asthma that lead to increased peripheral blood eosinophil counts (for example, allergic Bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, eosinophilia syndrome). COPD with mainly asthma can be included;
- Asthma subjects:Any disease that has not been stabilized by the investigator, including but not limited to unstable cardiovascular, gastrointestinal, liver, kidney, nervous system, musculoskeletal, infectious, endocrine, metabolic, hematology, mental illness or major physical injury , May: affect the safety of the subject during the entire study period, affect the research results or interpretation of the results, and hinder the subject's ability to complete the entire study period.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450052
Xiaojian Zhang, Bachelor, +86-0371-66295651, Zhxj0524@sina.com
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of TQC2731 Injection in Healthy Adult Subjects and Patients With Severe Asthma
This is the first-in-human phase 1 trial of TQC2731 injection in healthy subjects and in patients with severe asthma to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity.
- Conditions
- Asthma Severe Persistent Controlled
- Being tested
- TQC2731, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC2731Drug
TQC2731 injection
PlaceboDrug
Matching placebo with no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| TQC2731 injection(sc.) in healthy subjects | Experimental | For the single ascending dose (SAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of TQC2731(12mg、105mg、210mg、420mg、630mg) once.
For the multiple ascending dose (MAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of 420mg TQC2731 . Receives: Drug: TQC2731 |
| Matching Placebo(sc.) in healthy subjects | Placebo comparator | For the single ascending dose (SAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of matching placebo(12mg、105mg、210mg、420mg、630mg) once.
For the multiple ascending dose (MAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of 420mg matching placebo(12mg、105mg、210mg、420mg、630mg). Receives: Drug: Placebo |
| TQC2731 injection(SAD,iv.) | Experimental | Healthy subjects received 210mg TQC2731 intravenously (iv.) once. Receives: Drug: TQC2731 |
| Matching Placebo(SAD,iv.) | Placebo comparator | Healthy subjects received 210mg matching placebo intravenously (iv.) once. Receives: Drug: Placebo |
| TQC2731 injection(sc.) in asthma subjects | Experimental | For the multiple ascending dose (MAD) portion of the study, asthma subjects received subcutaneous(sc.) injection of TQC2731(70mg、210mg、280mg) . Receives: Drug: TQC2731 |
| Matching Placebo(sc.) in asthma subjects | Placebo comparator | For the multiple ascending dose (MAD) portion of the study, asthma subjects received subcutaneous(sc.) injection of matching placebo(70mg、210mg、280mg) . Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(healthy subject)Number of participants with abnormal clinical symptoms
Measured: appropriatly up to Day 253
(healthy subject)Number of participants with abnormal physical examination
Measured: appropriatly up to Day 253
(healthy subject)Number of participants with abnormal vital signs
Measured: appropriatly up to Day 253
(asthma subject)Number of participants with abnormal laboratory examinations
Measured: appropriatly up to Day 253
Secondary outcomes (11)
Area under the drug-time curve
Measured: up to Day 253
Maximum Concentration
Measured: up to Day 253
Time to maximum concentration following drug administration
Measured: up to Day 253
Apparent terminal elimination half-life following drug administration
Measured: up to Day 253
Apparent volume of distribution
Measured: up to Day 253
Clearance rate
Measured: up to Day 253
Incidence and titer of anti-drug antibody (ADA)
Measured: up to Day 253
Changes in forced expiratory volume (FEV1) in the first second before bronchodilator (before BD administration) from baseline
Measured: up to Day 253
Changes in exhaled nitric oxide FENO (ppb) in the first second before bronchodilator (before BD administration) from baseline
Measured: up to Day 253
exhaled nitric oxide FENO (ppb), peripheral blood eosinophils, and total serum IgE
Measured: up to Day 253
Annualized incidence of acute asthma attack (AAER) and degree
Measured: up to Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start25 Jun 2021 (estimated)
- Primary completion25 Aug 2023 (estimated)
- Study completion25 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma Severe Persistent ControlledStudies 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
- 96 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
- NCT04923607
- Sponsor's protocol ID
- TQC2731-I-01
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of TQC2731 Injection in Healthy Adult Subjects and Patients With Severe Asthma
- ClinicalTrials.gov ID
- NCT04923607
- Acronym / sponsor ID
- TQC2731-I-01
- Conditions
- Asthma Severe Persistent Controlled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (estimated)
- Primary completion
- 25 Aug 2023 (estimated)
- Study completion
- 25 Aug 2023 (estimated)
- First posted
- 11 Jun 2021 (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 the first-in-human phase 1 trial of TQC2731 injection in healthy subjects and in patients with severe asthma to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TQC2731 injection(sc.) in healthy subjects | Experimental | Drug: TQC2731For the single ascending dose (SAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of TQC2731(12mg、105mg、210mg、420mg、630mg) once. For the multiple ascending dose (MAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of 420mg TQC2731 . |
| Matching Placebo(sc.) in healthy subjects | Placebo comparator | Drug: PlaceboFor the single ascending dose (SAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of matching placebo(12mg、105mg、210mg、420mg、630mg) once. For the multiple ascending dose (MAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of 420mg matching placebo(12mg、105mg、210mg、420mg、630mg). |
| TQC2731 injection(SAD,iv.) | Experimental | Drug: TQC2731Healthy subjects received 210mg TQC2731 intravenously (iv.) once. |
| Matching Placebo(SAD,iv.) | Placebo comparator | Drug: PlaceboHealthy subjects received 210mg matching placebo intravenously (iv.) once. |
| TQC2731 injection(sc.) in asthma subjects | Experimental | Drug: TQC2731For the multiple ascending dose (MAD) portion of the study, asthma subjects received subcutaneous(sc.) injection of TQC2731(70mg、210mg、280mg) . |
| Matching Placebo(sc.) in asthma subjects | Placebo comparator | Drug: PlaceboFor the multiple ascending dose (MAD) portion of the study, asthma subjects received subcutaneous(sc.) injection of matching placebo(70mg、210mg、280mg) . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects:Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions.
- Healthy subjects:Aged between 18 and 60 years old, both men and women;
- Healthy subjects:Female ≥45kg, male ≥50kg, body mass index (BMI) is 18-28 kg/m^2 (including the critical value), BMI=weight (kg)/height^2 (m^2);
- Asthma subjects:Aged between 18 and 70 years old, both men and women;
- Asthma subjects:Female ≥45kg, male ≥50kg;
Key exclusion criteria (11 listed)
- Healthy subjects: Pregnant and lactating women;
- Healthy subjects:preexisting or existing heart, endocrine, metabolism, kidney, liver, gastrointestinal, skin, infection, blood, nerve, mental diseases or abnormalities, or related chronic or acute diseases, the investigator assesses that it is not appropriate to participate in the trial;
- Healthy subjects:Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, and chest radiograph during the screening period are abnormal and have clinical significance;
- Healthy subjects:Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) and Treponema pallidum antibody (Anti-TP), any of the above positive subjects;
- Healthy subjects:A history of clinically significant infections before and during screening, including upper respiratory tract infection (URTI) and lower respiratory tract infection (LRTI), and requires 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 |
|---|---|---|
| TQC2731TQC2731 injection | Drug | TQC2731 injection(SAD,iv.), TQC2731 injection(sc.) in asthma subjects, TQC2731 injection(sc.) in healthy subjects |
| PlaceboMatching placebo with no active ingredients | Drug | Matching Placebo(SAD,iv.), Matching Placebo(sc.) in asthma subjects, Matching Placebo(sc.) in healthy subjects |
Primary outcome
(healthy subject)Number of participants with abnormal clinical symptoms
Time frame: appropriatly up to Day 253
(healthy subject)Number of participants with abnormal physical examination
Time frame: appropriatly up to Day 253
(healthy subject)Number of participants with abnormal vital signs
Time frame: appropriatly up to Day 253
(asthma subject)Number of participants with abnormal laboratory examinations
Time frame: appropriatly up to Day 253
11 secondary outcomes
Area under the drug-time curve
Time frame: up to Day 253
Maximum Concentration
Time frame: up to Day 253
Time to maximum concentration following drug administration
Time frame: up to Day 253
Apparent terminal elimination half-life following drug administration
Time frame: up to Day 253
Apparent volume of distribution
Time frame: up to Day 253
Clearance rate
Time frame: up to Day 253
Incidence and titer of anti-drug antibody (ADA)
Time frame: up to Day 253
Changes in forced expiratory volume (FEV1) in the first second before bronchodilator (before BD administration) from baseline
Time frame: up to Day 253
Changes in exhaled nitric oxide FENO (ppb) in the first second before bronchodilator (before BD administration) from baseline
Time frame: up to Day 253
exhaled nitric oxide FENO (ppb), peripheral blood eosinophils, and total serum IgE
Time frame: up to Day 253
Annualized incidence of acute asthma attack (AAER) and degree
Time frame: up to Day 253
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
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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 TQC2731 in people with Asthma Severe Persistent Controlled, 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 6 inclusion and 11 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 11 Jun 2021. 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 Xiaojian Zhang, Bachelor (+86-0371-66295651, Zhxj0524@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(healthy subject)Number of participants with abnormal clinical symptoms (time frame: appropriatly up to Day 253). The study lists 4 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 11 Jun 2021.