A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers Safety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

Phase I, cohort-based, single-ascending dose study of subcutaneous FT-104 HCl in healthy volunteers with up to six cohorts (each up to 8 participants; sentinel dosing and Safety Review Committee–managed escalation).

Primary endpoints are safety, tolerability and PK (Cmax, Tmax, AUCs, t1/2) with intensive sampling through 24 hours and a follow-up visit at Day 10. Safety monitoring includes AEs/SAEs, vitals, ECG, labs and injection-site assessments; suicidality monitored using C-SSRS.