Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy Subjects
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PKs) of rhEGF eyedrops after the administration of single and multiple doses in healthy subjects. A phase 1, randomized, double-blind, placebo-controlled, and single-ascending dose (SAD) and multiple-ascending...
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MDPI AG
2022-10-01
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| Online Access: | https://www.mdpi.com/1424-8247/15/11/1312 |
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| author | Hyounggyoon Yoo Seonghae Yoon In-Jin Jang Kyung-Sang Yu Joon Young Hyon Jungi Hwang Inyoung Hwang Jung Sunwoo Jae-Yong Chung |
| author_facet | Hyounggyoon Yoo Seonghae Yoon In-Jin Jang Kyung-Sang Yu Joon Young Hyon Jungi Hwang Inyoung Hwang Jung Sunwoo Jae-Yong Chung |
| author_sort | Hyounggyoon Yoo |
| collection | DOAJ |
| description | The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PKs) of rhEGF eyedrops after the administration of single and multiple doses in healthy subjects. A phase 1, randomized, double-blind, placebo-controlled, and single-ascending dose (SAD) and multiple-ascending dose (MAD) study were conducted in three dose groups (10, 50, and 100 μg/mL). The subjects randomly received rhEGF eyedrops or the 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 studies, respectively. In addition, the serum and tear EGF concentrations were measured. Immunogenicity evaluations were conducted using serum anti-EGF antibody levels. 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 h without any serum EGF level change after the administration of rhEGF eyedrops. rhEGF eyedrops were safe and well-tolerated in healthy subjects in a dose range of 10–100 μg/mL, indicating suitability for further studies in patients with corneal injury. |
| first_indexed | 2024-03-09T18:45:34Z |
| format | Article |
| id | doaj.art-eebaae5c84d44d0885c8e466f134bc51 |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-09T18:45:34Z |
| publishDate | 2022-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-eebaae5c84d44d0885c8e466f134bc512023-11-24T06:17:54ZengMDPI AGPharmaceuticals1424-82472022-10-011511131210.3390/ph15111312Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy SubjectsHyounggyoon Yoo0Seonghae Yoon1In-Jin Jang2Kyung-Sang Yu3Joon Young Hyon4Jungi Hwang5Inyoung Hwang6Jung Sunwoo7Jae-Yong Chung8Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul 03080, KoreaDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul 03080, KoreaDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul 03080, KoreaDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul 03080, KoreaDepartment of Ophthalmology, Seoul National University College of Medicine, Seoul 03080, KoreaDepartment of Clinical Pharmacology and Therapeutics, Chungbuk National University Hospital, Cheongju 28644, KoreaDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul 03080, KoreaDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul 03080, KoreaDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul 03080, KoreaThe purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PKs) of rhEGF eyedrops after the administration of single and multiple doses in healthy subjects. A phase 1, randomized, double-blind, placebo-controlled, and single-ascending dose (SAD) and multiple-ascending dose (MAD) study were conducted in three dose groups (10, 50, and 100 μg/mL). The subjects randomly received rhEGF eyedrops or the 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 studies, respectively. In addition, the serum and tear EGF concentrations were measured. Immunogenicity evaluations were conducted using serum anti-EGF antibody levels. 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 h without any serum EGF level change after the administration of rhEGF eyedrops. rhEGF eyedrops were safe and well-tolerated in healthy subjects in a dose range of 10–100 μg/mL, indicating suitability for further studies in patients with corneal injury.https://www.mdpi.com/1424-8247/15/11/1312dry eye diseaseepidermal growth factorfirst-in-human studypharmacokinetics |
| spellingShingle | Hyounggyoon Yoo Seonghae Yoon In-Jin Jang Kyung-Sang Yu Joon Young Hyon Jungi Hwang Inyoung Hwang Jung Sunwoo Jae-Yong Chung Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy Subjects Pharmaceuticals dry eye disease epidermal growth factor first-in-human study pharmacokinetics |
| title | Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy Subjects |
| title_full | Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy Subjects |
| title_fullStr | Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy Subjects |
| title_full_unstemmed | Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy Subjects |
| title_short | Safety, Tolerability, and Serum/Tear Pharmacokinetics of Human Recombinant Epidermal Growth Factor Eyedrops in Healthy Subjects |
| title_sort | safety tolerability and serum tear pharmacokinetics of human recombinant epidermal growth factor eyedrops in healthy subjects |
| topic | dry eye disease epidermal growth factor first-in-human study pharmacokinetics |
| url | https://www.mdpi.com/1424-8247/15/11/1312 |
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