- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07589439
Dose-Ranging Study of LQ036 Single-Domain Antibody Nebulization Solution in Poorly Controlled Asthma
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of LQ036 Single-Domain Antibody Nebulization Solution in Patients With Poorly Controlled Asthma
What is the goal of this study? The goal of this clinical trial is to find out whether the study drug LQ036 (a nebulized solution taken by inhaling through a nebulizer) works to improve lung function and asthma control in people whose asthma is not well controlled. The study will also learn about the safety of LQ036, how the body processes it, and whether the body develops an immune response to it.
What are the main questions?
The most important question is:
• Does LQ036 improve lung function (measured by FEV₁ - the amount of air you can blow out in one second) more than a placebo at Week 12?
Other important questions include:
- Does LQ036 improve lung function at other time points (weeks 1, 2, 4, 8, 16, 20, 24)?
- Does LQ036 reduce asthma attacks (sudden worsening of asthma that needs extra treatment)?
- Does LQ036 help people use less rescue medication (inhaler for quick relief) and have more days without asthma symptoms?
- Does LQ036 improve scores on asthma control and quality of life questionnaires?
- What medical problems do participants have when taking LQ036?
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Meng Huang
- Phone Number: 86+02120985259
- Email: mhuang@novamab.com
Study Locations
-
-
-
Shanghai, China
- Recruiting
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
-
Contact:
- Jieming Qu, Principal Investigator
- Phone Number: 680801 +86-21-64370045
- Email: Jmqu0906@163.com
-
Contact:
- Wei Tang, Principal Investigator
- Phone Number: 680801 +86-21-64370045
- Email: Tw10986@rjh.com.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Outpatients, aged 12 to 75 years inclusive, male or female, with body mass index (BMI) between 18 and 30 kg/m² inclusive. For participants aged 12 to 17 years, body weight must be ≥30 kg.
- Diagnosed with bronchial asthma according to the 2025 Global Initiative for Asthma (GINA) guidelines prior to screening, with a documented history of asthma for ≥12 months.
- For at least 3 months prior to screening, the participant has used inhaled corticosteroids (ICS) combined with at least one controller medication, and has maintained a stable treatment regimen and dosage for at least 1 month prior to screening. Low, medium, and high maintenance doses of ICS are defined according to the 2025 GINA guidelines (if multiple nebulized or combined administration methods are used, doses are to be combined).
- At screening, pre-bronchodilator FEV₁ is ≥40% and <80% of the predicted normal value. For participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and <85% of the predicted normal value.
- At screening, Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5.
- At screening, a positive bronchodilator reversibility test (increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL, 15-30 minutes after inhalation of 400 μg salbutamol). If the reversibility test does not reach the positive threshold, one additional test is permitted within 7 days (excluding the day of the initial test). Alternatively, documented evidence of a positive bronchodilator reversibility test within 12 months prior to screening is acceptable.
- At screening, blood eosinophil (EOS) count ≥150 cells/μL and fractional exhaled nitric oxide (FeNO) ≥25 ppb.
- Experienced ≥1 severe exacerbation within the 12 months prior to screening (not required for participants on low-dose ICS).
- Participants fully understand the purpose, nature, methods, and possible adverse reactions of the study, voluntarily agree to participate, and sign the informed consent form before any study procedures begin.
- At randomization, pre-bronchodilator FEV₁ has increased by ≤20% from the screening value, and remains ≥40% and <80% of the predicted normal value (for participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and <85% of the predicted normal value).
- At randomization, ACQ-5 score ≥1.5.
- At randomization, blood EOS count ≥150 cells/μL and FeNO ≥25 ppb.
- During the run-in period, participant compliance with run-in medication and background medication is ≥80% and ≤120%, compliance with daily diary completion is ≥80%, and there are complete data for at least 4 days within the 7 days prior to randomization.
Exclusion Criteria:
- Life-threatening asthma, defined as an asthma episode requiring intubation within 1 year prior to screening or during the run-in period, and/or a history of hypercapnia, respiratory arrest, hypoxic seizures, asthma-related syncopal episodes, etc.
- Experienced a severe asthma exacerbation within 1 month prior to screening.
- History of allergy to biologics, or known hypersensitivity to any component of the investigational product.
- Use of biologics (including but not limited to anti-IgE, anti-IL-5, anti-IL-5 receptor, anti-IL-4/13 receptor, anti-TSLP monoclonal antibodies, etc.) and/or systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to screening.
- Received intravenous immunoglobulin (IVIG) or allergen-specific immunotherapy (SIT) within 3 months prior to screening.
- Received systemic corticosteroids (excluding topical, ophthalmic, or intranasal corticosteroids), antibiotics, antifungals, antivirals, antiparasitic drugs, non-selective beta-blockers, or herbal medicines with anti-asthmatic effects within 1 month prior to screening or during the run-in period.
- Received live or attenuated vaccine within 3 months prior to screening, or plan to receive live or attenuated vaccine during the study period.
- Underwent bronchial thermoplasty within 12 months prior to screening.
- Underwent major surgery within 8 weeks prior to screening, or plans to undergo surgery requiring general anesthesia or hospitalization for >1 day during the study period.
- In the investigator's judgment, presence of respiratory diseases other than asthma, including but not limited to chronic obstructive pulmonary disease (COPD), asthma-COPD overlap syndrome (ACOS), or any other significant lung disease (e.g., active pneumonia, idiopathic pulmonary fibrosis, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, bronchiectasis, etc.), that may place the participant at undue risk or affect the evaluation of study results.
- Based on imaging and investigator judgment, presence of active tuberculosis or non-tuberculous mycobacterial infection, untreated latent tuberculosis, or history of incompletely treated tuberculosis.
- Active autoimmune disease or autoimmune disease requiring immunosuppressive therapy, such as rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.
- Blood EOS >1500 cells/μL at screening, or other systemic diseases that may cause elevated peripheral blood EOS count (e.g., hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis, etc.), which in the investigator's judgment may affect the evaluation of the drug.
- Known or suspected immunodeficiency, including history of invasive opportunistic infection (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) even if resolved; or presence of unusually frequent, recurrent, or prolonged infections suggestive of an immunocompromised state.
- Known parasitic infection, or suspected or high-risk parasitic infection in the investigator's judgment.
- Active infection (e.g., upper respiratory tract infection) within 1 month prior to screening or during the run-in period, or acute infection requiring systemic anti-infective therapy.
- History of lymphoproliferative disease or malignancy (participants with basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ are eligible if they have completed curative treatment and have had no evidence of recurrence for at least 12 months prior to signing informed consent), or other medical history that in the investigator's judgment may affect the evaluation of the drug.
- Presence of any other severe and/or uncontrolled disease or treatment that, in the investigator's judgment, may affect the evaluation of the drug, including but not limited to: severe neurological disease, severe mental disorder, uncontrolled diabetes mellitus, uncontrolled hypertension, major cardiovascular disease, corrected QT interval prolongation (male >450 ms, female >470 ms, Fridericia's formula), or persistent arrhythmia.
- Current smoker or cessation of smoking for <6 months; or former smoker with a smoking history of ≥10 pack-years (pack-years = [cigarettes per day / 20] × years of smoking).
- Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening (participants with positive HBsAg but HBV-DNA below the lower limit of detection, or positive HCV antibody but HCV-RNA below the lower limit of detection, are eligible).
- Participants with severe liver or kidney dysfunction, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × upper limit of normal (ULN), or serum creatinine >1.5 × ULN.
- Pregnant or breastfeeding women; women planning to become pregnant during the study or within 3 months after the end of the study; fertile women or men who, in the investigator's judgment, cannot use medically accepted reliable contraception from signing informed consent until 3 months after the last dose of study drug; positive pregnancy test result at screening or before randomization for fertile women.
- Participation in another clinical study of a drug or device within 3 months prior to signing informed consent, with use of investigational drug/device; or still within the follow-up period of another clinical study or within 5 half-lives of the investigational drug (whichever is longer) at the time of signing informed consent.
- History of blood donation or significant blood loss, blood transfusion, or use of blood products within 3 months prior to screening.
- Known or suspected non-compliance, drug abuse, substance abuse, or alcohol abuse (daily pure alcohol intake >40 g for males, >20 g for females).
- Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LQ036 12 mg
LQ036 12 mg solution for nebulization, once daily for 24 weeks.
|
LQ036 is a single-domain antibody formulated as a solution for nebulization.
Participants will self-administer the assigned dose once daily by inhaling the nebulized solution.
|
|
Experimental: LQ036 24 mg
LQ036 24 mg solution for nebulization, once daily for 24 weeks.
|
LQ036 is a single-domain antibody formulated as a solution for nebulization.
Participants will self-administer the assigned dose once daily by inhaling the nebulized solution.
|
|
Placebo Comparator: Placebo then Re-randomized to LQ036
Placebo solution for nebulization once daily for 12 weeks, followed by re-randomization (1:1) to either LQ036 12 mg or LQ036 24 mg solution for nebulization once daily for an additional 12 weeks.
|
LQ036 is a single-domain antibody formulated as a solution for nebulization.
Participants will self-administer the assigned dose once daily by inhaling the nebulized solution.
Placebo is a look-alike solution for nebulization that contains no active drug.
Participants will self-administer the placebo once daily by inhaling the nebulized solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time Frame: Baseline, Week 12
|
Baseline, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Change From Baseline in Pre-bronchodilator FEV1 at Week 12
Time Frame: Baseline, Week 12
|
Baseline, Week 12
|
|
|
Absolute and Percent Change From Baseline in Pre-bronchodilator FEV1 at Weeks 1, 2, 4, 8, 16, 20, 24
Time Frame: Baseline, Weeks 1, 2, 4, 8, 16, 20, 24
|
Baseline, Weeks 1, 2, 4, 8, 16, 20, 24
|
|
|
Absolute and Percent Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
|
|
Absolute and Percent Change From Baseline in Pre-bronchodilator FEV1% Predicted, Forced Vital Capacity (FVC), and Forced Expiratory Flow (FEF25%-75%) at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
|
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Absolute and Percent Change From Baseline in Post-bronchodilator FEV1 at Weeks 12 and 24
Time Frame: Baseline, Weeks 12, 24
|
Baseline, Weeks 12, 24
|
|
|
Annualized Rate of Composite Exacerbation (CompEx) Events During the Treatment Period
Time Frame: Baseline up to Week 24
|
Baseline up to Week 24
|
|
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Time to First Composite Exacerbation (CompEx) Event
Time Frame: Baseline up to Week 24
|
Baseline up to Week 24
|
|
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Annualized Rate of Loss of Asthma Control (LOAC) Events During the Treatment Period
Time Frame: Baseline up to Week 24
|
Baseline up to Week 24
|
|
|
Time to First Loss of Asthma Control (LOAC) Event
Time Frame: Baseline up to Week 24
|
Baseline up to Week 24
|
|
|
Annualized Rate of Severe Exacerbation (SevEx) Events During the Treatment Period (in participants with history of severe exacerbation in past 12 months)
Time Frame: Baseline up to Week 24
|
Baseline up to Week 24
|
|
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Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During the Treatment Period (in participants with history of severe exacerbation in past 12 months)
Time Frame: Baseline up to Week 24
|
Baseline up to Week 24
|
|
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Time to First Severe Exacerbation (SevEx) Event (in participants with history of severe exacerbation in past 12 months)
Time Frame: Baseline up to Week 28
|
Baseline up to Week 28
|
|
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Time to First Severe Exacerbation Event Resulting in Hospitalization or Emergency Room Visit (in participants with history of severe exacerbation in past 12 months)
Time Frame: Baseline up to Week 28
|
Baseline up to Week 28
|
|
|
Absolute Change From Baseline in Nighttime Asthma Symptom Scores at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
Nighttime asthma symptom score was determined using an AM (ante meridiem) symptom scoring system, which evaluated the participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as follows: 0 = No symptoms;
|
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
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Absolute Change From Baseline in Daytime Asthma Symptom Scores at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
Daytime asthma symptom score was determined using a PM (post meridiem) symptom scoring system, which evaluated the participant's overall asthma symptoms experienced during the day. It ranged from 0 to 5 as follows: 0 = No symptoms;
|
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
|
Absolute Change From Baseline in Average Daily Reliever Medication Use (puffs/day) at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
|
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Number of Reliever Medication-Free Days During the Treatment Period
Time Frame: Baseline up to Week 24
|
Baseline up to Week 24
|
|
|
Absolute Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Global Score at Weeks 12 and 24
Time Frame: Baseline, Weeks 12, 24
|
The Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ[S]) is a 32 item disease specific instrument measuring the functional impairments that are most important to adults with asthma.
Each item is scored on a 7 point Likert scale where 1 = maximal impairment and 7 = no impairment.
The global score is the mean of all 32 responses, ranging from 1 (severely impaired quality of life) to 7 (not impaired at all).
Higher scores indicate better quality of life.
A positive change from baseline indicates improvement.
|
Baseline, Weeks 12, 24
|
|
Absolute and Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Each Time Point
Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
|
|
Absolute Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Weeks 1, 2, 4, 8, 12, 16, 20, 24
Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze.
Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranging from 0 (no impairment) to 6 (maximum impairment).
ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled).
Higher score indicated lower asthma control.
|
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: From 2-week placebo run-in period up to Week 28
|
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug, regardless of causal relationship.
TEAEs are defined as AEs that start or worsen on or after the first dose of study drug.
|
From 2-week placebo run-in period up to Week 28
|
|
Safety Measures: Incidence and Severity of Serious Adverse Events (SAEs)
Time Frame: From Screening up to Week 28
|
A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
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From Screening up to Week 28
|
|
Safety Measures: Number of Participants With Abnormal Vital Signs of Potential Clinical Importance
Time Frame: From Screening up to Week 28
|
Vital signs assessments include systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiratory rate (bmp), heart rate (bpm) and body temperature (℃).
Clinically significant abnormalities are determined by the investigator based on pre-defined criteria or medical judgment.
|
From Screening up to Week 28
|
|
Safety Measures: Number of Participants With Clinically Significant Findings on Physical Examination
Time Frame: At Screening, Baseline (Week 0), Week 12 and 24.
|
Physical examination includes assessment of general appearance; skin; head, eyes, ears, nose and throat (HEENT); chest; abdomen; spine; extremities; nervous system; and lymph nodes.
Clinically significant findings are determined by the investigator based on pre-defined criteria or medical judgment.
|
At Screening, Baseline (Week 0), Week 12 and 24.
|
|
Safety Measures: Number of Participants With Abnormal Hematology Parameters of Potential Clinical Importance
Time Frame: At Screening, Baseline (Week 0), Week 4, 8, 12, 16, 20, 24, 28.
|
Hematology assessments include white blood cell count (WBC), white blood cell differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell count (RBC), hemoglobin (Hb), platelet count (PLT), and hematocrit (HCT).
Clinically significant abnormalities are determined by the investigator based on pre-defined criteria or medical judgment.
|
At Screening, Baseline (Week 0), Week 4, 8, 12, 16, 20, 24, 28.
|
|
Safety Measures: Number of Participants With Abnormal Clinical Chemistry Parameters of Potential Clinical Importance
Time Frame: At Screening, Baseline (Week 0), at Week 4, 8, 12, 16, 20, 24, 28.
|
Blood chemistry assessments include alanine aminotransferase (ALT); aspartate aminotransferase (AST); total protein (TP); albumin (ALB); total bilirubin (TBIL); direct bilirubin (DBIL); alkaline phosphatase (ALP); gamma-glutamyltransferase (gamma-GGT); serum creatinine (Cr); blood urea (UREA) or blood urea nitrogen (BUN); uric acid (UA); fasting glucose (GLU); triglycerides (TG); total cholesterol (CHOL); low-density lipoprotein cholesterol (LDL-C); high-density lipoprotein cholesterol (HDL-C); lactate dehydrogenase (LDH); and electrolytes (sodium [Na], potassium [K], chloride [Cl]).
Clinically significant abnormalities are determined by the investigator based on pre-defined criteria or medical judgment.
|
At Screening, Baseline (Week 0), at Week 4, 8, 12, 16, 20, 24, 28.
|
|
Safety Measures: Number of Participants With Abnormal Urinalysis Parameters of Potential Clinical Importance
Time Frame: At Screening, Baseline (Week 0), Week 4, 12, 24, 28.
|
Urinalysis assessments include leukocytes, red blood cells, protein, glucose, and urine pH.
Clinically significant abnormalities are determined by the investigator based on pre-defined criteria or medical judgment.
|
At Screening, Baseline (Week 0), Week 4, 12, 24, 28.
|
|
Safety Measures: Number of Participants With Potentially Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters
Time Frame: At Screening, Baseline (Week 0), Weeks 4, 12, 24 and 28
|
12-lead ECGs were recorded after participants had rested in a supine position for at least 5 minutes.
The following ECG parameters were assessed: heart rate, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's formula (QTcF, in ms; QTcF = QT/RR^0.33).
The clinical significance of any abnormalities was determined by the investigator based on predefined criteria.
|
At Screening, Baseline (Week 0), Weeks 4, 12, 24 and 28
|
|
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LQ036
Time Frame: Day 1, Week 2, 4, 12 or early termination
|
Maximum observed plasma concentration after nebulized inhalation.
Measured in ng/mL.
|
Day 1, Week 2, 4, 12 or early termination
|
|
Pharmacokinetics (PK): Time to Maximum Plasma Concentration (Tmax) of LQ036
Time Frame: Day 1, Week 2, 4, 12 or early termination
|
Time at which Cmax is observed following drug administration.
Measured in hours.
|
Day 1, Week 2, 4, 12 or early termination
|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve From Time 0 to t (AUC(0-t)) of LQ036
Time Frame: Day 1, Week 2, 4, 12 or early termination
|
Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t).
Measured in h·ng/mL.
|
Day 1, Week 2, 4, 12 or early termination
|
|
Pharmacokinetics (PK): Apparent Clearance (CL/F) of LQ036
Time Frame: Day 1, Week 2, 4, 12 or early termination
|
Apparent clearance after nebulized inhalation, calculated as Dose/AUC(0-∞).
Measured in L/h.
|
Day 1, Week 2, 4, 12 or early termination
|
|
Pharmacokinetics (PK): Apparent Volume of Distribution (Vd/F) of LQ036
Time Frame: Day 1, Week 2, 4, 12 or early termination
|
Apparent volume of distribution during terminal phase after nebulized inhalation, calculated as (CL/F)/λz.
Measured in L.
|
Day 1, Week 2, 4, 12 or early termination
|
|
Pharmacokinetics (PK): Terminal Half Life (t1/2) of LQ036
Time Frame: Day 1, Week 2, 4, 12 or early termination
|
Terminal phase half life calculated as ln(2)/λz.
Measured in hours.
|
Day 1, Week 2, 4, 12 or early termination
|
|
Pharmacokinetics (PK): Trough Plasma Concentration (Ctrough) of LQ036
Time Frame: Week 2, 4, 12 or early termination
|
Plasma concentration at the end of a dosing interval just before the next dose.
Measured in ng/mL.
|
Week 2, 4, 12 or early termination
|
|
Pharmacokinetics (PK): Last Measurable Plasma Concentration (Clast) of LQ036
Time Frame: After last dose
|
Last measurable concentration above the limit of quantification.
Measured in ng/mL.
|
After last dose
|
|
Pharmacokinetics (PK): Time of Last Measurable Concentration (Tlast) of LQ036
Time Frame: After last dose
|
Time at which Clast is observed after the last dose.
Measured in hours.
|
After last dose
|
|
Drug Concentration in Bronchoalveolar Lavage Fluid (if applicable)
Time Frame: Between Week 16 to Week 24
|
Between Week 16 to Week 24
|
|
|
Immunogenicity: Incidence and Titer of Anti-Drug Antibodies (ADA) and Incidence of Neutralizing Antibodies (Nab)
Time Frame: Baseline, Weeks 2, 4, 12, 20, 24, 28
|
Baseline, Weeks 2, 4, 12, 20, 24, 28
|
|
|
Exploratory outcome: Absolute and Percent Change From Baseline in Induced Sputum Eosinophils (EOS) at Each Time Point (if applicable)
Time Frame: Baseline, Weeks 12, 24
|
Baseline, Weeks 12, 24
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LQSW-LQ036-CN-IIb
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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