drugset / Trial / NCT04074837
Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to examine the safety, tolerability and pharmacokinetics of single and multiple doses of NNI-362 in healthy aged population.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2021-07-31
- Completion
- 2021-08-15
Publications
- Kelleher-Andersson J, Yoon E, Green C, McFarlane C, Bagheri D, Thomas LP, Turner RS. First-in-human study of neuron regenerative therapy NNI-362 to evaluate the safety, pharmacokinetics, and pharmacodynamics in healthy aged population. Alzheimers Res Ther. 2025 Aug 7;17(1):185. doi: 10.1186/s13195-025-01837-0.
- Sumien N, Wells MS, Sidhu A, Wong JM, Forster MJ, Zheng QX, Kelleher-Andersson JA. Novel pharmacotherapy: NNI-362, an allosteric p70S6 kinase stimulator, reverses cognitive and neural regenerative deficits in models of aging and disease. Stem Cell Res Ther. 2021 Jan 13;12(1):59. doi: 10.1186/s13287-020-02126-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NNI-362 | Small molecule | 10 mg | Oral |
| Comparator | NNI-362 | Small molecule | 20 mg | Oral |
| Comparator | NNI-362 | Small molecule | 60 mg | Oral |
| Comparator | NNI-362 | Small molecule | 120 mg | Oral |
| Comparator | NNI-362 | Small molecule | 240 mg | Oral |