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Safety, tolerability, and serum/tear pharmacokinetics of human recombinant epidermal growth factor eyedrops in healthy subjects
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  • Hyounggyoon Yoo,
  • Seonghae Yoon,
  • In-Jin Jang,
  • Kyung-Sang Yu,
  • Joon Young Hyon,
  • Jungi Hwang,
  • Inyoung Hwang,
  • Jung Sunwoo,
  • Jae-Yong Chung
Hyounggyoon Yoo
Seoul National University College of Medicine

Corresponding Author:[email protected]

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Seonghae Yoon
Seoul National University College of Medicine
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In-Jin Jang
Seoul National University College of Medicine
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Kyung-Sang Yu
Seoul National University College of Medicine
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Joon Young Hyon
Seoul National University College of Medicine
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Jungi Hwang
Chungbuk National University Hospital
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Inyoung Hwang
Seoul National University College of Medicine
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Jung Sunwoo
Seoul National University College of Medicine
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Jae-Yong Chung
Seoul National University College of Medicine
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Abstract

Aims: The aim of this study was to evaluate the safety/tolerability, and pharmacokinetics (PKs) of rhEGF eyedrops after administration of a single and multiple doses in healthy subjects. Methods: A phase 1, randomized, double-blind, placebo-controlled, and single ascending dose (SAD) and multiple ascending dose (MAD) study were conducted in 3 dose groups (10, 50, and 100 μg/mL). The subjects randomly received rhEGF eyedrops or their placebo in a 3:1 ratio. Serial blood and tear samples for PK analysis were collected up to 36 h and 180 h post-dose in SAD and MAD study, respectively. In addition, the serum and tear EGF concentrations were measured. Immunogenicity evaluations were conducted using serum anti-EGF antibody level. Results: A total of 50 subjects were enrolled and 48 subjects completed the study. Adverse drug reactions were mild and transient. There were no serious adverse events in this study. The tear EGF concentrations rapidly increased and returned to baseline after 4 hours without serum EGF level change after the administration of rhEGF eyedrops. Conclusion: rhEGF eyedrops were safe and well-tolerated in healthy subjects in a dose range of 10-100 μg/mL, which indicated it was suitable for further studies for corneal injury patients.
24 Oct 2022Published in Pharmaceuticals volume 15 issue 11 on pages 1312. 10.3390/ph15111312