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New biologic GB-0895 enters first human safety trial for asthma and COPD

NCT ID NCT07116889

Disease control Sponsor: Generate Biomedicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage study is testing an experimental drug called GB-0895 in 156 adults with mild-to-moderate asthma or COPD. The main goal is to check if the drug is safe and how the body processes it. Participants receive either the drug or a placebo as an injection under the skin. This is a first-in-human trial, so there is no proof yet that GB-0895 improves breathing or disease control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GB-0895 (an experimental biologic drug given as an injection under the skin)
What this could lead to
If safe and effective, GB-0895 could become a new treatment option to help control asthma or COPD symptoms.
What could go wrong
This is a very early Phase 1 trial focused on safety, not on whether the drug works. It involves only 156 people, so results may not apply to everyone. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

asthma chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma COPD (chronic obstructive pulmonary disease)

Contacts and locations

Locations

  • Alcanza

    DeLand, Florida, 32720, United States

  • Charite Research Organization GmbH

    Berlin, Germany

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM)

    Hanover, Germany

  • Hammersmith Medicines Research

    London, United Kingdom

  • IKF Pneumologie

    Frankfurt, Germany

  • Medicines Evaluation Unit (MEU)

    Manchester, United Kingdom

  • Miami Research Institute of South Florida

    Miami, Florida, 33173, United States

  • Nucleus Network

    Saint Paul, Minnesota, 55114, United States

  • Omega Research

    Orlando, Florida, 32808, United States

  • Queen Anne Street Medical Center

    London, United Kingdom

  • Simbec-Orion Clinical Development

    Merthyr Tydfil, United Kingdom

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

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