drugset
drugset / Trial / NCT07334249

First-In-Human (FIH), Single Ascending Dose (SAD) Study and Multiple Ascending Dose (MAD) Study of SP-101 Injection

NCT07334249 ↗

Phase 1 Not yet recruiting 80 enrolled Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The goal of this First-In-Human (FIH) trial is to learn about safety, tolerability and pharmacokinetics of single and multiple ascending doses of SP-101 in healthy adult volunteers.

Timeline

Start
2025-12-23
Primary completion
2026-06-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified — Intravenous

Indications

major depressive disorder