A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD
NCT07116889
Phase
Phase 1
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Generate Biomedicines
Start date
2023-12-12
Number of sites
- Summary
- This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
- Short title
- A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD
- 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)
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-05-01
- First posted
- 2025-08-12
- Registry last updated
- 2025-11-05
- Primary completion date
- 2027-05-01
- Start date
- 2023-12-12
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Generate Biomedicines
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07116889
- ClinicalTrials.gov ID
- NCT07116889
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
Number of participants with treatment related adverse events as assessed by CTCAE 5.0
Timeframe: Day 1 to Day 500
Measure of maximum plasma concentration of GB-0895
Timeframe: Day 1 to Day 500
Total exposure of GB-0895 (AUC)
Timeframe: Day 1 to Day 500
Blood eosinophil counts
Timeframe: Day 1 to Day 500
Incidence of treatment-emergent anti-drug antibody (ADA) response
Timeframe: Day 1 to Day 500
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
Inclusion Criteria (Part A & B, Asthma):
- Participants must be able to give written consent
- 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
Exclusion Criteria (Part A & B, Asthma):
- Other serious disease
- Significant asthma exacerbations
- Current smokers or ex-smokers with >5 pack years smoking history
- Pregnant or breastfeeding
Inclusion Criteria (Part C, COPD):
- 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 (Part C, COPD):
- Other serious disease
- COPD exacerbation within 4 weeks of enrolling
- Requires supplemental oxygen (CPAP for sleep apnea allowed)
- Pregnant or breastfeeding
Sources for eligibility
- AlcanzaDeLand, United States
- Miami Research Institute of South FloridaMiami, United States
- Omega ResearchOrlando, United States
- Nucleus NetworkSaint Paul, United States
- Southeastern Research CenterWinston-Salem, United States
- DM Clinical ResearchTomball, United States
- Charite Research Organization GmbHBerlin, Germany
- IKF PneumologieFrankfurt, Germany
- Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)Hanover, Germany
- Hammersmith Medicines ResearchLondon, United Kingdom
- Queen Anne Street Medical CenterLondon, United Kingdom
- Medicines Evaluation Unit (MEU)Manchester, United Kingdom
- Simbec-Orion Clinical DevelopmentMerthyr Tydfil, United Kingdom
Sources for sites
- 2023
- 2023-507611-35-00
- 1008606
Sources for references
Related records
Drugs (1)
Lead sponsors (1)
Conditions (3)
- Asthma Primary condition
- Chronic obstructive pulmonary disease
- COPD, severe early onset