Meng, Xianmin
Wang, Qianqian
Wu, Shunquan
Pu, Di
Zhang, Amber
Fang, Sun
Zhou, Xuan
Lu, Hongzhou http://orcid.org/0000-0002-8308-5534
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetics and Safety of Intravenous and Subcutaneous Auto-injector Single-dose Belimumab in Healthy Chinese Volunteers: A phase 1, Randomized, Open-label Study
https://doi.org/10.1007/s40744-021-00366-0
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
https://doi.org/10.1136/ard-2022-222505
Funding for this research was provided by:
GlaxoSmithKline
Article History
Received: 25 May 2021
Accepted: 25 August 2021
First Online: 23 September 2021
Declarations
:
: Xuan Zhou is an employee of GSK and holds stocks and shares in the company. Shunquan Wu, Di Pu, Amber Zhang and Sun Fang were employees of GSK at the time of the study. Amber Zhang and Sun Fang held stocks and shares in the company. Shunquan Wu’s new affiliation is China SHIYAO Pharmaceutical Group Co., Ltd. Di Pu's new affiliation is FibroGen China. Amber Zhang’s new affiliation is Fresenius-kabi China Co., Ltd. Sun Fang's new affiliation is Shanghai LianBio Development Co., Ltd. Xianmin Meng, Qianqian Wang and Hongzhou Lu have nothing to disclose.
: The study procedure, any amendments, informed consent, and any other information required pre-approval were in accordance with the ethical standards of the national, regional, or investigational center ethics committee or institutional review board, in accordance with the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and applicable country-specific requirements, including US 21 Code of Federal Regulations (CFR) 312.3(b) for constitution of independent ethics committees. Investigators were trained and provided written commitments to perform the study in accordance with GCPs, the approved study protocol, as defined in ICH E3, Sect. 9.6, all applicable subject privacy requirements and the ethical principles in the Declaration of Helsinki. Informed consent was obtained from all healthy volunteers included in the study.