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

NCT07334249 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder, Healthy Volunteer

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.

Sponsors & Collaborators

  • Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-23
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07334249 on ClinicalTrials.gov