clinical trial · NCT07334249
First-In-Human (FIH), Single Ascending Dose (SAD) Study and Multiple Ascending Dose (MAD) Study of SP-101 Injection
Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.·phase1·not yet recruiting·n = 80
Major Depressive Disorder, Healthy VolunteerSP-101 injectionPlacebo
brief 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.
started
Dec 23, 2025
primary completion
Jun 30, 2026
completion
Dec 31, 2026
last updated
Jan 12, 2026
official title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SP-101 Injection Following Single and Multiple Intravenous Doses in Healthy Adult Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol