A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD
NCT ID: NCT07116889
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
156 participants
INTERVENTIONAL
2023-12-12
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part A: Single Ascending Dose (SAD) (asthma participants)
randomized 3:1 active:placebo
GB-0895 (SC)
Single subcutaneous dose of GB-0895
Placebo (SC)
Single subcutaneous dose of placebo
Part B: Multiple Ascending Dose (MAD) (asthma participants)
randomized 3:1 active:placebo
GB-0895 (SC)
Multiple subcutaneous doses of GB-0895
Placebo (SC)
Multiple subcutaneous doses of placebo
Part C: Single Dose (COPD participants)
randomized 3:1 active:placebo
GB-0895 (SC)
Single subcutaneous dose of GB-0895
Placebo (SC)
Single subcutaneous dose of placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 18 to 65 years of age (inclusive) at the screening visit;
* Diagnoses of mild to moderate asthma for ≥12 months
* Laboratory blood values within the ranges outlined in the protocol
* Participants must be able to give written consent
* 40 to 80 years of age (inclusive) at the screening visit;
* Diagnoses of COPD for ≥12 months
* Laboratory blood values within the ranges outlined in the protocol
* Must be current or ex-smoker
Exclusion Criteria
* Significant asthma exacerbations
* Current smokers or ex-smokers with \>5 pack years smoking history
* Pregnant or breastfeeding
* Other serious disease
* COPD exacerbation within 4 weeks of enrolling
* Requires supplemental oxygen (CPAP for sleep apnea allowed)
* Pregnant or breastfeeding
18 Years
80 Years
ALL
No
Sponsors
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Generate Biomedicines
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2023-507611-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
1008606
Identifier Type: REGISTRY
Identifier Source: secondary_id
GB-0895-101
Identifier Type: -
Identifier Source: org_study_id
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