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

NCT07334249 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SP-CN_101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder, Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events, throughout study completion

  Through study completion, an average of 10 days for SAD and an average of 28 days for MAD

Secondary Outcomes (7)

• Pharmacokinetic Parameter-AUC₀-inf

  From 0 hour before dosing to 72 hours after dosing

• Pharmacokinetic Parameter-AUC₀-last

  From 0 hour before dosing to 72 hours after dosing

• Pharmacokinetic Parameter-Cmax

  From 0 hour before dosing to 72 hours after dosing

• Pharmacokinetic Parameter-Tmax

  From 0 hour before dosing to 72 hours after dosing

• Pharmacokinetic Parameter-T½

  From 0 hour before dosing to 72 hours after dosing

Study Arms (2)

Investigational Drug group, SP-101 injection

EXPERIMENTAL

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.

Drug: SP-101 injection

Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

SP-101 injection DRUG

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

Investigational Drug group, SP-101 injection

Placebo DRUG

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to sign written informed consent;
• Aged 18 to 45 years old (inclusive), healthy males or females (male-to-female ratio is 1:1);
• Efficient contraceptive mean required by the protocol, and no plans for fertility, sperm donation or egg donation until 3 months after the last intravenous infusion;
• Body weight:≥50 kg (Male),≥45 kg (Female), Body Mass Index (BMI) of 18 to 28 kg/m2;
• Normal laboratory tests results, physical examination, medical history and surgical history review, 12-lead Electrocardiogram recording, and with no evidence of active and chronic diseases;
• willing and able to comply with all study procedures, restrictions, and visit schedules and to communicate effectively with the investigator;

You may not qualify if:

• Individuals with special dietary requirements who cannot adhere to a unified diet (e.g., intolerance to standard meal foods, or those with dysphagia);
• History of intolerance to IV infusion (e.g., severe pain) or unsuitable venous access (e.g., sclerotic, atrophic veins), difficulties with or contraindications to blood sampling; or a history of needle- or blood-injury-related phobia or syncope;
• Lactation or a positive pregnancy test at screening or baseline;
• Any febrile illness or active infection within 14 days prior to the first dose;
• Evidence of drug / substance abuse within the past 5 years, and/or habitual use of any drugs/substances, or a positive urine drug test at screening or baseline;
• Abnormal renal function (eGFR \< 90 mL/min/1.73 m²);
• History of QTc prolongation or demonstration of a clinically relevant ECG abnormality at screening;
• Excessive consumption of nicotine products within 3 months prior to screening (average daily cigarette consumption \>5 cigarettes), or inability to stop using any tobacco products during the trial, or a positive nicotine test;
• Previous participation in this study; treatment with an investigational product within 30 days prior to study initiation; or planning participation in another clinical trial during the study period;
• Positive test result at screening for any of the following: hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV), antibody to human immunodeficiency virus (anti-HIV), or treponemal antibody for syphilis;
• Any abnormal results during screening that is deemed clinically significant by the investigator, e.g., resting pulse \<55 or \>100 bpm; SBP ≥140 or \<90 mmHg; DBP ≥100 or \<60 mmHg, or ECG, or abnormal laboratory tests results, clinically relevant;
• Significant blood loss (≥200 mL) within 60 days prior to dosing（including trauma, blood sampling, blood donation, etc.）; or planning blood donation during the study or within 30 days post-dose;
• History of alcohol abuse, or average weekly alcohol consumption greater than 14 units within 3 months prior to screening or a positive alcohol breath test at baseline or inability to abstain from alcohol for the duration of the study;
• Excessive daily consumption of tea, coffee, and/or caffeine-rich beverages for a prolonged period within 3 months prior to screening; or intake of xanthine/caffeine-containing or grapefruit-containing foods or beverages (e.g., coffee, strong tea, chocolate, grapefruit) within 24 hours prior to the first intravenous infusion;
• Using any prescription drugs, OTC medications (excluding hormonal contraceptives, topically applied eye/nose drops and creams with no systemic exposure risk), Chinese herbal medicines, or food supplements such as vitamins and calcium supplements within 14 days prior to screening or during the screening period, unless prior approval has been obtained from the Investigator and Sponsor;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Mental Health Center (SMHC)

Shanghai, Shanghai Municipality, 200030, China

Location

Related Links

• WHO website has shared some Background information
• Data and information of the marketed drug (Spravato), the same targeting at NMDAR, have been key reference for study design of this protocol.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

HECHUN WANG

CONTACT

+8613911873347; hechunwang@synphatec.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 12, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

CN (1)