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NCT Number: NCT07116889

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Bronchial Diseases COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charite Research Organization GmbH, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GB-0895 (SC)

Biological

Single subcutaneous dose of GB-0895

Placebo (SC)

Drug

Single subcutaneous dose of placebo

Primary outcomes

  1. Number of participants with treatment related adverse events as assessed by CTCAE 5.0

    Time frame: Day 1 to Day 500

Secondary outcomes

  1. Measure of maximum plasma concentration of GB-0895

    Time frame: Day 1 to Day 500

  2. Total exposure of GB-0895 (AUC)

    Time frame: Day 1 to Day 500

  3. Blood eosinophil counts

    Time frame: Day 1 to Day 500

  4. Incidence of treatment-emergent anti-drug antibody (ADA) response

    Time frame: Day 1 to Day 500

Sponsors and collaborators

Lead sponsor

Generate Biomedicines

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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