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

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)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07116889

Enrollment

156

Registered

2025-08-12

Start date

2023-12-12

Completion date

2027-05-31

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Generate Biomedicines

Brief summary

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

Interventions

BIOLOGICALGB-0895 (SC)

Single subcutaneous dose of GB-0895

DRUGPlacebo (SC)

Single subcutaneous dose of placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with treatment related adverse events as assessed by CTCAE 5.0	Day 1 to Day 500

Secondary

Measure	Time frame
Measure of maximum plasma concentration of GB-0895	Day 1 to Day 500
Total exposure of GB-0895 (AUC)	Day 1 to Day 500
Blood eosinophil counts	Day 1 to Day 500
Incidence of treatment-emergent anti-drug antibody (ADA) response	Day 1 to Day 500

Countries

Germany, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026