NCT06175351
Active, not recruiting
Phase 1
A Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Clinical Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Phase 1
- Intervention
- 9MW1911
- Conditions
- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Enrollment
- 80
- Locations
- 22
- Primary Endpoint
- Safety and tolerability
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The study will evaluate the pharmacokinetic characteristics, safety, tolerability, and preliminary efficacy of 9MW1911 in combination with standard of care COPD maintenance therapy in patients with moderate to severe COPD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients must be \>=40 years of age and capable of giving signed informed consent.
- •Body Mass Index (BMI) of 16 kg/m² to 32 kg/m².
- •Documented physician diagnosis of COPD for at least 1 year.
- •Smoking history with a minimum of 10 pack-year.
- •Post-bronchodilator of FEV1\>=30 and \<80% of predicted normal value at screening.
- •Modified Medical Research Council (dyspnea scale) (mMRC) score\>=
- •COPD assessment score (CAT) score \>=10, with each of the phlegm and cough items with a score \>=
- •Documented stable, standard-of-care COPD maintenance therapy for at least 8 weeks prior to screening, with no anticipated changes during the screening period and throughout the study.
- •Documented history of \>= 2 moderate or \>=1 severe COPD exacerbations within 12 months prior to screening.
Exclusion Criteria
- •Current diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines, or documented history of asthma.
- •Diagnosis of Alpha-1 Antitrypsin Deficiency.
- •Moderate to severe COPD exacerbation, within 4 weeks prior to randomization.
- •History of lung pneumonectomy, or lung volume reduction within 12 months prior to screening.
- •Clinically significant respiratory disease other than COPD that significantly affect the study.
- •Evidence of active injection with Mycobacterium tuberculosis or nontuberculous mycobacteria, latent, or inadequately treated infection with Mycobacterium tuberculosis.
- •COVID-19 vaccination injection within 14 days before randomization.
- •Long-term treatment with oxygen (oxygen therapy time \>15h/day), or treatment with mechanical ventilation
- •Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).
- •Participating in, or scheduled for a pulmonary rehabilitation program within 4 weeks of screening.
Arms & Interventions
Phase Ib 9MW1911
9MW1911 is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 6 patients.
Intervention: 9MW1911
Phase IIa 9MW1911
9MW1911 is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 18 patients.
Intervention: 9MW1911
Phase Ib Placebo
Placebo is administered intravenously in a multiple ascending dose pattern in four dose levels. Each level includes 2 patients.
Intervention: Placebo
Phase IIa Placebo
Placebo is administered intravenously (two doses selected on phase Ib). Each dose level includes up to 6 patients.
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: 36 weeks
The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit
Pharmacokinetic characteristics.
Time Frame: 36 weeks
Accumulation ratio based on peak concentration (Rac (Cmax))
Secondary Outcomes
- Changes from baseline in post-bronchodilator FEV1.(Weeks 0, 4, 8, 12, 24)
- Changes from baseline in post-brochodilator FEV1(%pred).(Weeks 0, 4, 8, 12, 24)
- Time to first moderate to severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 24.(Baseline to week 24.)
- Annualized rate of moderate to severe AECOPD over the 24-week treatment period.(24 weeks)
- Changes from baseline in mMRC(Modified Medical Research Council) dyspnea scale at 12 and 24 weeks.(Weeks 0, 12, 24)
- Changes from baseline in CAT(COPD Assessment Test) score at 12 and 24 weeks.(Weeks 0, 12, 24)
- Changes from baseline in pre-bronchodilator FEV1 (forced expiratory volume at one second).(Weeks 0, 4, 8, 12, 24)
- Incidence of ADAs Against 9MW1911.(36 weeks)
Study Sites (22)
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