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

Generate Biomedicines

Status and phase: Enrolling; Phase 1

Conditions: Asthma; COPD (Chronic Obstructive Pulmonary Disease)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07116889

2023-507611-35-00 (EU Trial (CTIS) Number)

1008606 (Registry Identifier)

GB-0895-101

Details and patient eligibility

About

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

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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156 participants in 3 patient groups

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

Experimental group

Description:

randomized 3:1 active:placebo

Treatment:

Biological: GB-0895 (SC)

Drug: Placebo (SC)

Drug: Placebo (SC)

Biological: GB-0895 (SC)

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

Experimental group

Description:

randomized 3:1 active:placebo

Treatment:

Biological: GB-0895 (SC)

Drug: Placebo (SC)

Drug: Placebo (SC)

Biological: GB-0895 (SC)

Part C: Single Dose (COPD participants)

Experimental group

Description:

randomized 3:1 active:placebo

Treatment:

Biological: GB-0895 (SC)

Drug: Placebo (SC)

Drug: Placebo (SC)

Biological: GB-0895 (SC)