> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-study-to-investigate-gb-0895-in-adults-with-mild-to-3cffc44d-2b08-43bf-b3c5-bac395c23c21
> Record changed: 2026-10-13

# A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD

NCT07116889

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

Participants

156

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

Lead sponsor

Generate Biomedicines

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

Start date

2023-12-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

Number of sites

13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Title and summary

**Summary**

This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Short title**

A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**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)

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Status and phase

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Dates

**Completion date**

2027-05-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**First posted**

2025-08-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Registry last updated**

2025-11-05

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Primary completion date**

2027-05-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Start date**

2023-12-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Size and sites

**Participants**

156

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Planned participants**

156

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Number of sites**

13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Lead sponsor**

Generate Biomedicines

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Identifiers

**Registry ID**

NCT07116889

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**ClinicalTrials.gov ID**

NCT07116889

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Study design

**Allocation**

Randomised

**Model**

Sequential

**Purpose**

Treatment

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Outcomes

### Primary outcomes

1. Number of participants with treatment related adverse events as assessed by CTCAE 5.0  
Timeframe: Day 1 to Day 500

### Secondary outcomes

1. Measure of maximum plasma concentration of GB-0895  
Timeframe: Day 1 to Day 500
2. Total exposure of GB-0895 (AUC)  
Timeframe: Day 1 to Day 500
3. Blood eosinophil counts  
Timeframe: Day 1 to Day 500
4. Incidence of treatment-emergent anti-drug antibody (ADA) response  
Timeframe: Day 1 to Day 500

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Eligibility

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Sites

- 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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## References

### Other registry identifiers (3)

- 2023
- 2023-507611-35-00
- 1008606

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116889)

## Related records

### Drugs (1)

- [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md)

### Lead sponsors (1)

- [Generate Biomedicines](https://trialight.com/data/company/generate-biomedicines-3250c137-4965-48f3-bc4c-3c8e3a96daf5.md)

### Conditions (3)

- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition
- [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md)
- [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md)

### Targets (2)

- [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md)
- [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md)

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