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NOT YET RECRUITING
NCT07334249
PHASE1

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

Sponsor: Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-12-23

Completion Date

2026-12-31

Last Updated

2026-01-12

Healthy Volunteers

Yes

Interventions

DRUG

SP-101 injection

SP-101 is non-competitive antagonist against NMDA receptor and is administered by intravenous infusion.

DRUG

Placebo

Participants will be randomly assigned to the experimental group and placebo groups at ratio of 3:1. Participants assigned to the experimental group will be administered SP-101 by intravenous infusion. Accordingly, participants assigned to the placebo group will be administered placebo by intravenous infusion.

Locations (1)

Shanghai Mental Health Center (SMHC)

Shanghai, Shanghai Municipality, China