Clinical Trial

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

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated January 12, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07334249
Lead Sponsor Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.
Conditions Major Depressive Disorder, Healthy Volunteer
Enrollment 80 participants
Start Date 2025-12-23
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-12