Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma

A Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Effects of Subcutaneously Administered REGN3500 in Adult Patients With Moderate Asthma

Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.

Key Inclusion Criteria:

• Body mass index (BMI) of 18 to 32 kg/m2
• A diagnosis of moderate asthma (according to GINA 2015) for a period of at least 2 years prior to screening.
• Patient must use a stable medium daily dose level of inhaled corticosteroids (ICS) as defined by GINA guidelines, ie, total daily dose of ICS >400 μg and ≤800 μg/day of budesonide or equivalent for at least 1 month prior to screening and during the study
• A pre-bronchodilator forced expiratory volume in the first sec (FEV1) ≥60% and ≤90% of the predicted normal values at screening and pre-dose at screening
• A documented positive response to the reversibility test at the screening, defined as improvement in FEV1 ≥12% and ≥200 mL over baseline after 400 μg salbutamol Pmdi
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent.

Key Exclusion Criteria:

• Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening.
• Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to screening.
• History of life-threatening asthma
• Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening.
• Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2016); or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease).
• Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening.
• Use of oral antibiotics/anti-infectives within 2 weeks prior to screening.
• Known sensitivity to doxycycline or tetracyclines, or to any of the components of the investigational product formulation.
• Recent (within the previous 2 months) bacterial, protozoal, viral, or parasite infection.
• History of tuberculosis or systemic fungal diseases
• Patients treated with a monoclonal antibody based therapy (such as an anti-IgE, anti-IL-5), a biologic therapy or immunotherapy (subcutaneous immunotherapy [SCIT], sublingual immunotherapy [SLIT], or oral immunotherapy [OIT]) in the previous 12 weeks prior to screening and during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply