Clinical trial • Phase I • Respiratory
GB-0895 for Asthma | Chronic obstructive pulmonary disease
Phase I trial of GB-0895 for Asthma | Chronic obstructive pulmonary disease. 70 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Asthma | Chronic obstructive pulmonary disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 14-11-2023
- First CTIS Authorization Date
- 09-02-2024
Trial design
Phase I trial across 3 sites in Germany.
- Target Sample Size
- 70
Eligibility
Recruits 70 Vulnerable population selected; no details provided on consent or assent handling..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling.
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 70
Germany
- Earliest CTIS Part Ii Submission Date
- 03-01-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 784
- Number Of Sites
- 3
- Number Of Participants
- 70
Sites
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- IKF Pneumologie GmbH & Co. KG
- Principal Investigator Name
- Marc Oliver Kornmann
- Principal Investigator Email
- kornmann@ikf-pneumologie.de
- Contact Person Name
- Marc Oliver Kornmann
- Contact Person Email
- kornmann@ikf-pneumologie.de
- Site Name
- The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
- Department Name
- The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
- Principal Investigator Name
- Philipp Badorrek
- Principal Investigator Email
- philipp.badorrek@item.fraunhofer.de
- Contact Person Name
- Philipp Badorrek
- Contact Person Email
- philipp.badorrek@item.fraunhofer.de
- Site Name
- Charite Research Organisation GmbH
- Principal Investigator Name
- Stanislav Ignatenko
- Principal Investigator Email
- stanislav.ignatenko@charite-research.org
- Contact Person Name
- Stanislav Ignatenko
- Contact Person Email
- stanislav.ignatenko@charite-research.org
Sponsor
Primary sponsor
- Full Name
- Generate Biomedicines Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- GB-0895
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