AsthmaPhase 1NCT07116889
A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD
A Phase 1 study testing GB-0895 (SC) in people with Asthma and COPD (Chronic Obstructive Pulmonary Disease), run by Generate Biomedicines at 13 sites in 3 countries.
Trial summary
This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- GB-0895 (SC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 12 Dec 2023to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Participants must be able to give written consent
- 40 to 80 years of age (inclusive) at the screening visit;
Show all 9Show fewer
- Diagnoses of COPD for ≥12 months
- Laboratory blood values within the ranges outlined in the protocol
- Must be current or ex-smoker
Who cannot join
- Other serious disease
- 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
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States6 sites
Alcanza
DeLand, Florida, 32720
Miami Research Institute of South Florida
Miami, Florida, 33173
Omega Research
Orlando, Florida, 32808
Nucleus Network
Saint Paul, Minnesota, 55114
DM Clinical Research
Tomball, Texas, 77375
Southeastern Research Center
Winston-Salem, North Carolina, 27103
United Kingdom4 sites
Hammersmith Medicines Research
London
Queen Anne Street Medical Center
London
Medicines Evaluation Unit (MEU)
Manchester
Simbec-Orion Clinical Development
Merthyr Tydfil
Germany3 sites
Charite Research Organization GmbH
Berlin
IKF Pneumologie
Frankfurt
Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)
Hanover
About this study
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)
This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
- Being tested
- GB-0895 (SC), Placebo (SC)
- Keywords
- Generate Biomedicines
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-0895 (SC)Biological
Single subcutaneous dose of GB-0895
GB-0895 (SC)Biological
Multiple subcutaneous doses of GB-0895
Placebo (SC)Drug
Single subcutaneous dose of placebo
Placebo (SC)Drug
Multiple subcutaneous doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) (asthma participants) | Experimental | randomized 3:1 active:placebo Receives: Biological: GB-0895 (SC); Drug: Placebo (SC) |
| Part B: Multiple Ascending Dose (MAD) (asthma participants) | Experimental | randomized 3:1 active:placebo Receives: Biological: GB-0895 (SC); Drug: Placebo (SC) |
| Part C: Single Dose (COPD participants) | Experimental | randomized 3:1 active:placebo Receives: Biological: GB-0895 (SC); Drug: Placebo (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment related adverse events as assessed by CTCAE 5.0
Measured: Day 1 to Day 500
Secondary outcomes (4)
Measure of maximum plasma concentration of GB-0895
Measured: Day 1 to Day 500
Total exposure of GB-0895 (AUC)
Measured: Day 1 to Day 500
Blood eosinophil counts
Measured: Day 1 to Day 500
Incidence of treatment-emergent anti-drug antibody (ADA) response
Measured: Day 1 to Day 500
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start12 Dec 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Generate Biomedicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116889
- Sponsor's protocol ID
- GB-0895-101
- Other IDs
- 2023-507611-35-00, 1008606, 2023
- Status last verified
- Nov 2025
- First submitted
- 23 Jul 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07116889
- Acronym / sponsor ID
- GB-0895-101
- Keywords
- Generate Biomedicines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Generate BiomedicinesIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) (asthma participants) | Experimental | Biological: GB-0895 (SC), Drug: Placebo (SC)randomized 3:1 active:placebo |
| Part B: Multiple Ascending Dose (MAD) (asthma participants) | Experimental | Biological: GB-0895 (SC), Drug: Placebo (SC)randomized 3:1 active:placebo |
| Part C: Single Dose (COPD participants) | Experimental | Biological: GB-0895 (SC), Drug: Placebo (SC)randomized 3:1 active:placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Participants must be able to give written consent
Key exclusion criteria (8 listed)
- Other serious disease
- Significant asthma exacerbations
- Current smokers or ex-smokers with >5 pack years smoking history
- Pregnant or breastfeeding
- Other serious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-0895 (SC)Single subcutaneous dose of GB-0895 | Biological | Part A: Single Ascending Dose (SAD) (asthma participants), Part C: Single Dose (COPD participants) |
| GB-0895 (SC)Multiple subcutaneous doses of GB-0895 | Biological | Part B: Multiple Ascending Dose (MAD) (asthma participants) |
| Placebo (SC)Single subcutaneous dose of placebo | Drug | Part A: Single Ascending Dose (SAD) (asthma participants), Part C: Single Dose (COPD participants) |
| Placebo (SC)Multiple subcutaneous doses of placebo | Drug | Part B: Multiple Ascending Dose (MAD) (asthma participants) |
Primary outcome
Number of participants with treatment related adverse events as assessed by CTCAE 5.0
Time frame: Day 1 to Day 500
4 secondary outcomes
Measure of maximum plasma concentration of GB-0895
Time frame: Day 1 to Day 500
Total exposure of GB-0895 (AUC)
Time frame: Day 1 to Day 500
Blood eosinophil counts
Time frame: Day 1 to Day 500
Incidence of treatment-emergent anti-drug antibody (ADA) response
Time frame: Day 1 to Day 500
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB-0895 (SC) in people with Asthma and COPD (Chronic Obstructive Pulmonary Disease), run by Generate Biomedicines at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment related adverse events as assessed by CTCAE 5.0 (time frame: Day 1 to Day 500). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.