Clinical Trial of GX-I7 in Healthy Volunteers

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7 in healthy volunteers.

Timeline

Start

2016-07-11

Primary completion

2017-01-20

Completion

2018-06-02

Publications

• Background Kang MC, Choi DH, Choi YW, Park SJ, Namkoong H, Park KS, Ahn SS, Surh CD, Yoon SW, Kim DJ, Choi JA, Park Y, Sung YC, Lee SW. Intranasal Introduction of Fc-Fused Interleukin-7 Provides Long-Lasting Prophylaxis against Lethal Influenza Virus Infection. J Virol. 2015 Dec 9;90(5):2273-84. doi: 10.1128/JVI.02768-15.
• Background Seo YB, Im SJ, Namkoong H, Kim SW, Choi YW, Kang MC, Lim HS, Jin HT, Yang SH, Cho ML, Kim YM, Lee SW, Choi YK, Surh CD, Sung YC. Crucial roles of interleukin-7 in the development of T follicular helper cells and in the induction of humoral immunity. J Virol. 2014 Aug;88(16):8998-9009. doi: 10.1128/JVI.00534-14. Epub 2014 Jun 4.
• Background Ahn SS, Jeon BY, Park SJ, Choi DH, Ku SH, Cho SN, Sung YC. Nonlytic Fc-fused IL-7 synergizes with Mtb32 DNA vaccine to enhance antigen-specific T cell responses in a therapeutic model of tuberculosis. Vaccine. 2013 Jun 12;31(27):2884-90. doi: 10.1016/j.vaccine.2013.04.029. Epub 2013 Apr 23.
• Background Martin CE, van Leeuwen EM, Im SJ, Roopenian DC, Sung YC, Surh CD. IL-7/anti-IL-7 mAb complexes augment cytokine potency in mice through association with IgG-Fc and by competition with IL-7R. Blood. 2013 May 30;121(22):4484-92. doi: 10.1182/blood-2012-08-449215. Epub 2013 Apr 22.
• Background Nam HJ, Song MY, Choi DH, Yang SH, Jin HT, Sung YC. Marked enhancement of antigen-specific T-cell responses by IL-7-fused nonlytic, but not lytic, Fc as a genetic adjuvant. Eur J Immunol. 2010 Feb;40(2):351-8. doi: 10.1002/eji.200939271.
• Background Park SH, Song MY, Nam HJ, Im SJ, Sung YC. Codelivery of IL-7 Augments Multigenic HCV DNA Vaccine-induced Antibody as well as Broad T Cell Responses in Cynomolgus Monkeys. Immune Netw. 2010 Dec;10(6):198-205. doi: 10.4110/in.2010.10.6.198. Epub 2010 Dec 31.
• Lee SW, Choi D, Heo M, Shin EC, Park SH, Kim SJ, Oh YK, Lee BH, Yang SH, Sung YC, Lee H. hIL-7-hyFc, A Long-Acting IL-7, Increased Absolute Lymphocyte Count in Healthy Subjects. Clin Transl Sci. 2020 Nov;13(6):1161-1169. doi: 10.1111/cts.12800. Epub 2020 May 20.

Drugs

Indications

No indication recorded.