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A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD
Sponsor: Generate Biomedicines
Summary
This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
Official title: A Phase 1 First in Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GB-0895 in Adults With Mild to Moderate Asthma or Single Dose in Chronic Obstructive Pulmonary Disease (COPD)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2023-12-12
Completion Date
2027-05
Last Updated
2025-11-05
Healthy Volunteers
No
Interventions
GB-0895 (SC)
Single subcutaneous dose of GB-0895
GB-0895 (SC)
Multiple subcutaneous doses of GB-0895
Placebo (SC)
Single subcutaneous dose of placebo
Placebo (SC)
Multiple subcutaneous doses of placebo
Locations (13)
Alcanza
DeLand, Florida, United States
Miami Research Institute of South Florida
Miami, Florida, United States
Omega Research
Orlando, Florida, United States
Nucleus Network
Saint Paul, Minnesota, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
DM Clinical Research
Tomball, Texas, United States
Charite Research Organization GmbH
Berlin, Germany
IKF Pneumologie
Frankfurt, Germany
Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)
Hanover, Germany
Hammersmith Medicines Research
London, United Kingdom
Queen Anne Street Medical Center
London, United Kingdom
Medicines Evaluation Unit (MEU)
Manchester, United Kingdom
Simbec-Orion Clinical Development
Merthyr Tydfil, United Kingdom