A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion

Summary

Up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the study. The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation. A total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14 blood samples will be collected in each cohort for PD analysis.

Timeline

Start

2021-11-04

Primary completion

2022-08-19

Completion

2022-12-22

Publications

• Kim HB, Yoo S, Kwak H, Ma SX, Kim R, Lee M, Ha N, Pyo S, Kwon SG, Cho EH, Lee SM, Jang J, Kim WK, Park HC, Baek M, Park Y, Park JY, Park JW, Hwang SW, Hwang JI, Seong JY. Inhibition of FAM19A5 reverses synaptic loss and cognitive decline in mouse models of Alzheimer's disease. Alzheimers Res Ther. 2025 Jul 21;17(1):168. doi: 10.1186/s13195-025-01813-8.

Drugs

Indications