Jeon, Yoomin http://orcid.org/0000-0002-5134-065X
Lee, Nora http://orcid.org/0000-0001-7047-308X
Baek, Seungjae
Choi, JaeDuk
Jhee, Stanford http://orcid.org/0000-0002-0784-6522
Lee, Howard http://orcid.org/0000-0001-6713-5418
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects
https://doi.org/10.1007/s40268-021-00379-8
Funding for this research was provided by:
Hanmi Pharmaceutical Co., Ltd., (08-HM10460A-101)
Article History
Accepted: 13 December 2021
First Online: 6 January 2022
Declarations
:
: This study was sponsored by Hanmi Pharmaceutical Co., Ltd., (Protocol No. 08-HM10460A-101) Seoul, South Korea.
: NL, SB, and JDC are employees of Hanmi Pharmaceutical Co., Ltd. YJ and HL have no conflicts of interest to declare that are relevant to the contents of this article. SJ received funding from Hanmi Pharmaceutical Co., Ltd. to conduct this study.
: The datasets generated and/or analyzed are available from the corresponding author upon reasonable request.
: Not applicable.
: YJ and NL participated equally in the analysis and interpretation of data and wrote the manuscript. HL, SB, and JDC contributed to the analysis and interpretation of data. SJ contributed to the conception and design of the study, and the acquisition, analysis and interpretation of data. All authors reviewed and provided comments on the manuscript, and all authors read and approved the final manuscript.
: This study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonization Good Clinical Practice guidelines, and in compliance with local regulatory requirements. The study protocol was reviewed and approved by the Institutional Review Board (Aspire IRB).
: All participants provided written informed consent before they underwent screening for eligibility.
: All participants provided written informed consent for their data to be published.