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

Part of paid clinical trials in DeLand, Florida.

Sponsor
Generate Biomedicines
Study ID
NCT07116889
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Asthma
  • COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • GB-0895 (SC) — BIOLOGICAL
    Single subcutaneous dose of GB-0895
  • GB-0895 (SC) — BIOLOGICAL
    Multiple subcutaneous doses of GB-0895
  • Placebo (SC) — DRUG
    Single subcutaneous dose of placebo
  • Placebo (SC) — DRUG
    Multiple subcutaneous doses of placebo

Study Details

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

Key Dates

Start date
Dec 12, 2023
Status verified
Nov 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Single Ascending Dose (SAD) (asthma participants)
    randomized 3:1 active:placebo
  • Experimental: Part B: Multiple Ascending Dose (MAD) (asthma participants)
    randomized 3:1 active:placebo
  • Experimental: Part C: Single Dose (COPD participants)
    randomized 3:1 active:placebo

Primary Outcome Measure

Number of participants with treatment related adverse events as assessed by CTCAE 5.0 [ Time Frame: Day 1 to Day 500 ]

Locations (6)

FacilityCityStateZIPSite coordinators
AlcanzaDeLandFlorida32720-
Miami Research Institute of South FloridaMiamiFlorida33173-
Omega ResearchOrlandoFlorida32808-
Nucleus NetworkSaint PaulMinnesota55114-
Southeastern Research CenterWinston-SalemNorth Carolina27103-
DM Clinical ResearchTomballTexas77375-

Find similar trials in DeLand, FL

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Alcanza· DeLand, FLMiami Research Institute of South Florida· Miami, FLOmega Research· Orlando, FLNucleus Network· Saint Paul, MNSoutheastern Research Center· Winston-Salem, NCDM Clinical Research· Tomball, TX

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