Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection
ConditionCOPD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorZhejiang Kanova Biopharmaceutical Co., LTD
About this trial
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, two-stage design, Phase II clinical study. This study is divided into two stages. Stage 1 (Phase IIa) has a dosing duration of 24 weeks (treatment period of 28 weeks) and aims to preliminarily evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD. Stage 2 (Phase IIb) has a dosing duration of 48 weeks (treatment period of 52 weeks) and aims to further evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD.
Eligibility criteria
Qualifiers
The trial participant is able to understand the procedures and methods of this study, is willing to sign the ICF and strictly adhere to the clinical study protocol to complete this study, and can independently complete study-related questionnaires;
The trial participant must be aged 40-80 years (inclusive) at the time of signing the ICF, can be either male or female;
The trial participant has a BMI ≥16.0 kg/m2;
Current smoker or ex-smoker with a smoking history of ≥10 pack-years (1 pack-year is calculated as: [average number of cigarettes smoked per day × number of years]/20; e.g., 1 pack-year = smoking 20 cigarettes per day for 1 year, or smoking 10 cigarettes per day for 2 years.); Moderate to severe airflow limitation (post-bronchodilator FEV1/FVC <70%, post-bronchodilator FEV1 measurement ≥30% and <80% of predicted value);
Disqualifiers
Current diagnosis of asthma or a history of asthma according to the GINA or other recognized guidelines;
Diagnosis of alpha-1 antitrypsin deficiency;
Other concomitant active or clinically significant respiratory disorders that would significantly affect the study: such as active pulmonary tuberculosis, lung cancer (including suspected malignant pulmonary nodule [Category 4]), bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung disease, cystic fibrosis, obliterative bronchiolitis, pulmonary arterial hypertension, etc.;
AECOPD (including mild, moderate, and severe; for definitions of moderate and severe AECOPD, see Inclusion Criterion 4, item 3) and/or respiratory tract infection within 4 weeks prior to screening and before randomization;
Trial design
Treatments tested in this trial
- XKH001Injection
- Placebo
Treatment groups
75 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov