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Clinical Trials in the USA / NCT07116889
Active, not recruiting Phase 1

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

NCT07116889 · tracked via the Priya Life Science USA tracker
Sponsor
Generate Biomedicines
Phase
Phase 1
Started
2023-12-12
Last updated
2025-11-05

Condition(s) studied

AsthmaCOPD (Chronic Obstructive Pulmonary Disease)

Investigational drug(s) / intervention(s)

GB-0895 (SC) →GB-0895 (SC) →Placebo (SC)Placebo (SC)

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max 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

Primary outcome measure(s)

  • Number of participants with treatment related adverse events as assessed by CTCAE 5.0 — Day 1 to Day 500

Trial sites (13)

FacilityCityRegionStatus
Alcanza DeLand Florida
Miami Research Institute of South Florida Miami Florida
Omega Research Orlando Florida
Nucleus Network Saint Paul Minnesota
Southeastern Research Center Winston-Salem North Carolina
DM Clinical Research Tomball Texas
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

More Generate Biomedicines trials in the USA

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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1) Recruiting

Other trials for the same condition

Depemokimab Asthma Imaging and Bronchoscopy Sub-Study Recruiting
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma Recruiting
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma Recruiting
ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults Recruiting
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07116889 on ClinicalTrials.gov ↗ ← All trials in the USA