drugset / Trial / NCT03672604
A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is being developed as a potential treatment for neurodegenerative disorders including Parkinson's disease. This study is intended to identify the appropriate dose-range for evaluation in Parkinson's disease patients.
Timeline
- Start
- 2018-09-19
- Primary completion
- 2019-07-30
- Completion
- 2019-07-30
Publications
- Background Yun SP, Kam TI, Panicker N, Kim S, Oh Y, Park JS, Kwon SH, Park YJ, Karuppagounder SS, Park H, Kim S, Oh N, Kim NA, Lee S, Brahmachari S, Mao X, Lee JH, Kumar M, An D, Kang SU, Lee Y, Lee KC, Na DH, Kim D, Lee SH, Roschke VV, Liddelow SA, Mari Z, Barres BA, Dawson VL, Lee S, Dawson TM, Ko HS. Block of A1 astrocyte conversion by microglia is neuroprotective in models of Parkinson's disease. Nat Med. 2018 Jul;24(7):931-938. doi: 10.1038/s41591-018-0051-5. Epub 2018 Jun 11.
- Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NLY01 | Peptide | 0.25 mg | Subcutaneous |
| Comparator | NLY01 | Peptide | 0.8 mg | Subcutaneous |
| Comparator | NLY01 | Peptide | 2.5 mg | Subcutaneous |
| Comparator | NLY01 | Peptide | 5 mg | Subcutaneous |
| Comparator | NLY01 | Peptide | 10 mg | Subcutaneous |
Indications
No indication recorded.