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Authors
Lee, Ji Su
Kim, WonSerk
Won, Chong-Hyun
Lee, Yang-Won
Lee, SeungHwan
Won, Heejae
Park, Soon-Jae
Lee, Sunbae
Kim, Seol-Hee
Yang, Jiwon
Bahn, Gahee
Lee, Dong Hun
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Clinical Trials BETA
Clinical trials referenced in this document:
nct05232175 at ClinicalTrials.govDocuments that mention this clinical trial
The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers
https://doi.org/10.1007/s13555-025-01507-x
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Funding
Funding for this research was provided by:
Ministry of Science and ICT, South Korea (RS-2022-DD123890)
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Article History
Received: 16 June 2025
Accepted: 25 July 2025
First Online: 2 September 2025
Declarations
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: Soon-Jae Park, Sunbae Lee, Seol-Hee Kim, Jiwon Yang, and Gahee Bahn are employees of Alteogen Inc. Ji Su Lee, WonSerk Kim, Chong-Hyun Won, Yang-Won Lee, SeungHwan Lee, Heejae Won and Dong Hun Lee declare no conflincts of interest regarding the content of this article.
: This study was conducted in accordance with the ethical principles of the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice guidelines. The study protocol was reviewed and approved by the Institutional Review Boards of the following institutions: Seoul National University Hospital (IRB number: H-2111-014-1268), Asan Medical Center (IRB number: 2021-1793), Konkuk University Medical Center (IRB number: KUMC 2021-10-034), and Kangbuk Samsung Hospital (IRB number: KBSMC 2021-10-049). Written informed consent was obtained from all participants prior to study enrollment.
