๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-04

A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD (NCT07116889)

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)

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Generate Biomedicines

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Alcanza โ€” DeLand, Florida

Age range: 18 Years to 80 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (13 Sites)

  • Alcanza โ€” DeLand, Florida
  • Miami Research Institute of South Florida โ€” Miami, Florida
  • Omega Research โ€” Orlando, Florida
  • Nucleus Network โ€” Saint Paul, Minnesota
  • Southeastern Research Center โ€” Winston-Salem, North Carolina
  • DM Clinical Research โ€” Tomball, Texas
  • Charite Research Organization GmbH โ€” Berlin,
  • IKF Pneumologie โ€” Frankfurt,
  • Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM) โ€” Hanover,
  • Hammersmith Medicines Research โ€” London,
  • Queen Anne Street Medical Center โ€” London,
  • Medicines Evaluation Unit (MEU) โ€” Manchester,
  • Simbec-Orion Clinical Development โ€” Merthyr Tydfil,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Asthma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—