Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD)
NCT02077465 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2020-09-09
Summary
The primary objective of the study is to assess the safety and tolerability of multiple infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.
Conditions
Interventions
- DRUG
-
Andecaliximab
400 mg andecaliximab administered intravenously
- DRUG
-
Placebo to match Andecaliximab
Placebo to match andecaliximab administered intravenously
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-11
- Primary Completion
- 2014-10-27
- Completion
- 2014-10-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
NCT01362231 ·Status: COMPLETED ·Phase: PHASE1
-
Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)
NCT00783107 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis
NCT02950805 ·Status: COMPLETED ·Phase: PHASE1
-
Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
NCT03244059 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis
NCT01818544 ·Status: COMPLETED ·Phase: PHASE2
-
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
NCT06280391 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease
NCT05785624 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction.
NCT02075541 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT04968574 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis
NCT07201051 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
NCT05628740 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00961038 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)
NCT00506545 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT06317285 ·Status: TERMINATED ·Phase: PHASE2
-
The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects
NCT03502902 ·Status: COMPLETED ·Phase: PHASE1
-
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
NCT04456673 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
NCT01052298 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
NCT05010876 ·Status: COMPLETED ·Phase: PHASE2
-
A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
NCT07119229 ·Status: RECRUITING ·Phase: NA
-
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of the Dry Powder Formulation of GSK2269557 in Healthy Subjects
NCT01762878 ·Status: COMPLETED ·Phase: PHASE1
-
Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission Tomography (PET) Imaging
NCT03069989 ·Status: TERMINATED ·Phase: PHASE1
-
Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease
NCT04154826 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluation of S-600918 in Adults With Refractory Chronic Cough
NCT04110054 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT02105948 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
NCT04631016 ·Status: COMPLETED ·Phase: PHASE2