Clinical trial • Phase III • Other
andexanet alfa for Healthy volunteers
Phase III trial of andexanet alfa for Healthy volunteers. 78 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 17-10-2025
- First CTIS Authorization Date
- 09-01-2026
Trial design
Phase III trial across 1 site in Germany.
- Target Sample Size
- 78
Eligibility
Recruits 78 Vulnerable population selected; no consent or assent details provided in source documents..
- Vulnerable Population
- Vulnerable population selected; no consent or assent details provided in source documents.
Recruitment
- Planned Sample Size
- 78
- Recruitment Window Months
- 3
- Consent Approach
- No informed consent or assent details provided; vulnerable population selected.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 108
Germany
- Earliest CTIS Part Ii Submission Date
- 24-11-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 46
- Number Of Sites
- 1
- Number Of Participants
- 108
Sites
- Site Name
- Klinikum Westend Haus 31, Spandauer Damm 130, Charlottenburg
- Department Name
- 2601; Parexel Early Phase Unit Berlin
- Contact Person Name
- Bartlomiej Kozak
- Contact Person Email
- bartlomiej.kozak@parexel.com
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Contract research organisations
- Name
- PAREXEL International GmbH
Investigational products
- Investigational Product Name
- andexanet alfa
- Active Substance
- andexanet alfa
- Modality
- Peptide/protein/enzyme
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