NCT07116889

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_1 asthma

Timeline
12mo left

Started Dec 2023

Longer than P75 for phase_1 asthma

Geographic Reach
3 countries

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Dec 2023May 2027

Study Start

First participant enrolled

December 12, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

3.4 years

First QC Date

July 23, 2025

Last Update Submit

November 4, 2025

Conditions

AsthmaCOPD (Chronic Obstructive Pulmonary Disease)

Keywords

Generate Biomedicines

Outcome Measures

Primary Outcomes (1)

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

    Day 1 to Day 500

Secondary Outcomes (4)

  • 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

Study Arms (3)

Part A: Single Ascending Dose (SAD) (asthma participants)

EXPERIMENTAL

randomized 3:1 active:placebo

Biological: GB-0895 (SC)Drug: Placebo (SC)

Part B: Multiple Ascending Dose (MAD) (asthma participants)

EXPERIMENTAL

randomized 3:1 active:placebo

Biological: GB-0895 (SC)Drug: Placebo (SC)

Part C: Single Dose (COPD participants)

EXPERIMENTAL

randomized 3:1 active:placebo

Biological: GB-0895 (SC)Drug: Placebo (SC)

Interventions

GB-0895 (SC)BIOLOGICAL

Single subcutaneous dose of GB-0895

Part A: Single Ascending Dose (SAD) (asthma participants)Part C: Single Dose (COPD participants)
Placebo (SC)DRUG

Single subcutaneous dose of placebo

Part A: Single Ascending Dose (SAD) (asthma participants)Part C: Single Dose (COPD participants)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be able to give written consent
  • 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

You may not qualify if:

  • Other serious disease
  • Significant asthma exacerbations
  • Current smokers or ex-smokers with \>5 pack years smoking history
  • Pregnant or breastfeeding
  • Participants must be able to give written consent
  • 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
  • Other serious disease
  • COPD exacerbation within 4 weeks of enrolling
  • Requires supplemental oxygen (CPAP for sleep apnea allowed)
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Alcanza

DeLand, Florida, 32720, United States

Location

Miami Research Institute of South Florida

Miami, Florida, 33173, United States

Location

Omega Research

Orlando, Florida, 32808, United States

Location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Charite Research Organization GmbH

Berlin, Germany

Location

IKF Pneumologie

Frankfurt, Germany

Location

Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)

Hanover, Germany

Location

Hammersmith Medicines Research

London, United Kingdom

Location

Queen Anne Street Medical Center

London, United Kingdom

Location

Medicines Evaluation Unit (MEU)

Manchester, United Kingdom

Location

Simbec-Orion Clinical Development

Merthyr Tydfil, United Kingdom

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 12, 2025

Study Start

December 12, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(6)DE(3)GB(4)