hIL‐7‐hyFc, A Long‐Acting IL‐7, Increased Absolute Lymphocyte Count in Healthy Subjects
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SCOPUS
- Title
- hIL‐7‐hyFc, A Long‐Acting IL‐7, Increased Absolute Lymphocyte Count in Healthy Subjects
- Authors
- Lee, Sang Won; Choi, Donghoon; Heo, MinKyu; Shin, Eui‐Cheol; Park, Su‐Hyung; Kim, So Jeong; Oh, Yeon‐Kyung; Lee, Byung Ha; Yang, Se Hwan; SUNG, YOUNG CHUL; Lee, Howard
- Date Issued
- 2020-11
- Publisher
- Wiley-Blackwell
- Abstract
- A low lymphocyte count puts immune-compromised patients at risk of mortality. hIL-7-hyFc is a homodimeric interleukin-7 (IL-7), a potent T-cell amplifier, fused to the hybridizing IgD/IgG4 immunoglobulin domain. We performed a randomized, double-blind, placebo-controlled, dose-escalation, phase I study to assess the pharmacokinetic, pharmacodynamic, safety, tolerability, and immunogenicity profiles of hIL-7-hyFc administered s.c. and i.m. to healthy volunteers. Thirty subjects randomly received hIL-7-hyFc or its matching placebo in an 8:2 ratio at 20, 60 mu g/kg s.c., or 60 mu g/kg i.m. The hIL-7-hyFc was slowly absorbed and its terminal half-life was 63.26 hours after i.m. administration. The hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks. The hIL-7-hyFc was well-tolerated after a single s.c. and i.m. administration. Injection site reaction was the most common treatment-emergent adverse event, which resolved spontaneously without treatment. The hIL-7-hyFc can be developed into a beneficial treatment option for patients with compromised T-cell immunity. This trial was registered at as #NCT02860715.
- URI
- https://oasis.postech.ac.kr/handle/2014.oak/105413
- DOI
- 10.1111/cts.12800
- ISSN
- 1752-8054
- Article Type
- Article
- Citation
- Clinical and Translational Science, vol. 13, no. 6, page. 1161 - 1169, 2020-11
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- There are no files associated with this item.
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