Atopic DermatitisPhase 1NCT05409326
A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
A Phase 1 study testing TQH2722 injection in people with Atopic Dermatitis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- TQH2722 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jun 2022to 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1 The informed consent was signed before the trial, fully understood the purpose and process of the trial and the possible adverse reactions.
- 2 Aged 18 ~ 60 years old (including the critical value), both male and female;
- 3 ≥ 45 kg for females and ≥ 50 kg for males with a body mass index (BMI) between 19 and 26 kg/m2 inclusive, BMI = weight (kg)/height2 (m2)
- 4 The subject is able to communicate well with the investigator, voluntary and able to understand and follow protocol procedures to complete the study;
- 5 The subject agrees not to have a childbearing plan from the date of signing the informed consent form to 6 months after the last dose, and must use effective non-drug contraception with a partner of childbearing potential;
- 6 Normal physical examination, vital signs or abnormal physical examination, vital signs without clinical significance
Who cannot join
- 1 Females who are pregnant, lactating or have unprotected sex within two weeks prior to screening;
- 2 Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
- 3 People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, eye examination, 12-lead ECG and X-ray during screening period;
- 4 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);
- 5 Clinically significant respiratory infection requiring antibiotic or antiviral therapy within 7 days prior to randomization;
- 6 People who received surgical operation within 4 weeks prior to screening, or planned to receive surgical operation during the study period;
Show all 23Show fewer
- 7 People who participated in other clinical trials and took the study drug within 3 months before screening;
- 8 Received immunoglobulins or blood products within 30 days prior to randomization;
- 9 Blood loss or blood donation of more than 400 mL within 2 months prior to randomization;
- 10 People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness;
- 11 A history of allergic reactions to another therapeutic monoclonal antibody or biologic agent therapy, or any clear history of drug or food allergies, particularly those with allergies to similar components to the drug in this trial;
- 12 People who have received or are planning to receive live-reduced or active vaccines during the 30 days prior to randomization and the entire study period (including the follow-up period);
- 13 Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products during the 6 months prior to randomization and the entire study period (including the follow-up period);
- 14 People who had long-standing alcohol abuse or alcohol consumption of more than 14 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week during the 3 months prior to screening and the entire study period (including the follow-up period), or those who tested positive for alcohol breath;
- 15 People with a history of substance abuse or positive urine drug screening;
- 16 Received any marketed or research biologics within 4 months or 5 half-lives (whichever is longer) prior to randomization;
- 17 Taking any prescription, over-the-counter and herbal medicines within 4 weeks prior to randomization, with the exception of vitamin products;
- 18 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;
- 19 Parasitic infection is associated and is excluded if any of the following are met:
- During the screening period, the stool routinely checks positive for eggs;
- History of parasitic infection within 6 months prior to the screening period;
- Have traveled or planned to travel to endemic parasitic infection areas (including but not limited to Southeast and South-West Asia, South America and Africa) within 6 months prior to screening visits;
- 20 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, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yu Cao, Doctor, 0532-82917310, caoyu1767@126.com
About this study
Official title: A Phase I Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects.
- Conditions
- Atopic Dermatitis
- Being tested
- TQH2722 injection, Placebo to match TQH2722
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQH2722 injectionDrug
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
Placebo to match TQH2722Drug
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
| Study group | Role | What they receive |
|---|---|---|
| TQH2722 injection | Experimental | Participants will receive single dose of TQH2722 injection under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of TQH2722 injection once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43. Receives: Drug: TQH2722 injection |
| Placebo to match TQH2722 | Placebo comparator | Participants will receive single dose of matching placebo under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of matching placebo once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43. Receives: Drug: Placebo to match TQH2722 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
Incidence and severity of adverse events (AE) .
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Serious adverse events (SAE)
Incidence and severity of Serious adverse events (SAE).
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Blood biochemistry
Abnormal indicators of blood biochemistry.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Coagulation function
Abnormal indicators of coagulation function.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Blood routine
Abnormal indicators of blood routine.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Urinalysis
Abnormal indicators of urinalysis.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Blood pressure
Abnormal values of blood pressure
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Pulse
Abnormal values of blood pulse.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Body temperature
Abnormal values of blood body temperature.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Skin
Examination of the skin.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Mucous membranes
Examination of the mucous membranes.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Lymph nodes
Examination of the lymph nodes.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Head
Examination of the head.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Neck
Examination of the neck.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Chest
Examination of the chest.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abdomen
Examination of the abdomen.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Spine
Examination of the spine.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Limbs
Examination of the limbs.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
12-lead electrocardiogram
Abnormal values of 12-lead electrocardiogram
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Secondary outcomes (12)
Maximum Concentration（Cmax）
Maximum Concentration
Measured: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Minimum Concentration(Cmax)
Minimum Concentration
Measured: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Time to maximum concentration(Tmax)
Time to maximum concentration following drug administration
Measured: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Area under the drug-time curve(AUC)
Area under the drug-time curve
Measured: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Apparent terminal elimination half-life(t1/2)
Apparent terminal elimination half-life following drug administration
Measured: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Apparent volume of distribution(Vd/F)
Apparent volume of distribution
Measured: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Clearance rate(CL/F)
Clearance rate
Measured: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose
Immunoglobulin E(IgE)
Percentage of changes in serum IgE
Measured: SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Thymus activation regulates chemokines(TARC)
Percentage of changes in serum TARC
Measured: SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Anti-drug antibody (ADA)
Incidence and titer of anti-drug antibody
Measured: SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Neutralizing Antibody(Nab)
Incidence of Neutralizing Antibody
Measured: SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Injection site response
Injection site response assessment
Measured: Before administration,0.5,1,3,6 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409326
- Sponsor's protocol ID
- TQH2722-I-01
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Wang X, Zhu S, Sun F, Fu Y, Ban R, Tan H, Yin Z, Gao Z, Xu Z, Yu D, Cao Y. Safety, pharmacokinetics and population pharmacokinetic model of TQH2722, a novel IL-4Ralpha monoclonal antibody in healthy subjects: a phase I, first-in-human, single-dose and multiple-dose escalation study. J Pharm Sci. 2025 Jul;114(7):103773. doi: 10.1016/j.xphs.2025.103773. Epub 2025 Apr 10.
PubMed 40221092
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05409326
- Acronym / sponsor ID
- TQH2722-I-01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Jun 2022 (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.
A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in 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 |
|---|---|---|
| TQH2722 injection | Experimental | Drug: TQH2722 injectionParticipants will receive single dose of TQH2722 injection under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of TQH2722 injection once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43. |
| Placebo to match TQH2722 | Placebo comparator | Drug: Placebo to match TQH2722Participants will receive single dose of matching placebo under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of matching placebo once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1 The informed consent was signed before the trial, fully understood the purpose and process of the trial and the possible adverse reactions.
- 2 Aged 18 ~ 60 years old (including the critical value), both male and female;
- 3 ≥ 45 kg for females and ≥ 50 kg for males with a body mass index (BMI) between 19 and 26 kg/m2 inclusive, BMI = weight (kg)/height2 (m2)
- 4 The subject is able to communicate well with the investigator, voluntary and able to understand and follow protocol procedures to complete the study;
- 5 The subject agrees not to have a childbearing plan from the date of signing the informed consent form to 6 months after the last dose, and must use effective non-drug contraception with a partner of childbearing potential;
Key exclusion criteria (23 listed)
- 1 Females who are pregnant, lactating or have unprotected sex within two weeks prior to screening;
- 2 Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
- 3 People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, eye examination, 12-lead ECG and X-ray during screening period;
- 4 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);
- 5 Clinically significant respiratory infection requiring antibiotic or antiviral therapy within 7 days prior to randomization;
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 |
|---|---|---|
| TQH2722 injectionTQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases. | Drug | TQH2722 injection |
| Placebo to match TQH2722TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases. | Drug | Placebo to match TQH2722 |
Primary outcome
Adverse events (AE)
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Incidence and severity of adverse events (AE) .
Serious adverse events (SAE)
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Incidence and severity of Serious adverse events (SAE).
Blood biochemistry
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of blood biochemistry.
Coagulation function
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of coagulation function.
Blood routine
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of blood routine.
Urinalysis
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of urinalysis.
Blood pressure
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal values of blood pressure
Pulse
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal values of blood pulse.
Body temperature
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal values of blood body temperature.
Skin
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the skin.
Mucous membranes
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the mucous membranes.
Lymph nodes
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the lymph nodes.
Head
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the head.
Neck
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the neck.
Chest
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the chest.
Abdomen
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the abdomen.
Spine
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the spine.
Limbs
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Examination of the limbs.
12-lead electrocardiogram
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal values of 12-lead electrocardiogram
12 secondary outcomes
Maximum Concentration（Cmax）
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Minimum Concentration(Cmax)
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Time to maximum concentration(Tmax)
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Area under the drug-time curve(AUC)
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Apparent terminal elimination half-life(t1/2)
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Apparent volume of distribution(Vd/F)
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Clearance rate(CL/F)
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose
Immunoglobulin E(IgE)
Time frame: SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Thymus activation regulates chemokines(TARC)
Time frame: SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Anti-drug antibody (ADA)
Time frame: SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Neutralizing Antibody(Nab)
Time frame: SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Injection site response
Time frame: Before administration,0.5,1,3,6 hours after administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 40221092Li X, Wang X, Zhu S, Sun F, Fu Y, Ban R, Tan H, Yin Z, Gao Z, Xu Z, Yu D, Cao Y. Safety, pharmacokinetics and population pharmacokinetic model of TQH2722, a novel IL-4Ralpha monoclonal antibody in healthy subjects: a phase I, first-in-human, single-dose and multiple-dose escalation study. J Pharm Sci. 2025 Jul;114(7):103773. doi: 10.1016/j.xphs.2025.103773. Epub 2025 Apr 10.
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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 TQH2722 injection in people with Atopic Dermatitis, 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 6 inclusion and 23 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 8 Jun 2022. 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 Yu Cao, Doctor (0532-82917310, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) (time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409326, which also lists 1 linked publication.
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 8 Jun 2022.