Major Depressive Disorder, Healthy VolunteerPhase 1NCT07334249
First-In-Human (FIH), Single Ascending Dose (SAD) Study and Multiple Ascending Dose (MAD) Study of SP-101 Injection
A Phase 1 study testing SP-101 injection in people with Major Depressive Disorder, Healthy Volunteer, run by Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Healthy Volunteer
- What is being tested?
- SP-101 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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);
Show all 23Show fewer
- 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;
- Using any drugs that inhibit or induce the activity of hepatic drug-metabolizing enzymes within 30 days prior to screening;
- History of a major surgical procedure within the past 6 months prior to screening, or planned elective surgery during the course of the study;
- Current or past history of psychiatric and/or , neurological diseases, and abnormalities of the motor or sensory systems, whether confirmed or suspected;
- Any clinically significant disease, or any clinically significant illness, condition, or other finding that, in the investigator's opinion, would pose a risk to subject safety or interfere with the conduct, progress, or completion of the study.;
- History or current using of hallucinations, which is viewed unsuitable for by investigator;
- History or current presence of psychiatric disorders and/or brain dysfunction;
- History of known or suspected hypersensitivity or allergic reaction to any component of the investigational product or to related compounds, drugs, or foods;
- Any other condition or reason that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center (SMHC)
Shanghai, Shanghai Municipality, 200030
YIFENG SHEN, M.D., 86-21-34773657, shenyifeng@yahoo.com
YIFENG SHEN, M.D.
About this study
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
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.
- Being tested
- SP-101 injection, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-101 injectionDrug
SP-101 is non-competitive antagonist against NMDA receptor and is administered by intravenous infusion.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events, throughout study completion
Measured: 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
Area under the plasma concentration versus time curve (AUC) from time 0 to infinity
Measured: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-AUC₀-last
Area under the plasma concentration versus time curve (AUC) from time 0 to the last measurable concentration
Measured: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-Cmax
Peak Plasma Concentration (Cmax)
Measured: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-Tmax
Time to reach the Peak Plasma Concentration (Tmax)
Measured: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-T½
Elimination half life (T½)
Measured: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-CL
Apparent clearance (CL)
Measured: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter- Vz
apparent volume of distribution ( Vz)
Measured: From 0 hour before dosing to 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start23 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334249
- Sponsor's protocol ID
- SP-CN_101
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07334249
- Acronym / sponsor ID
- SP-CN_101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Drug group, SP-101 injection | Experimental | Drug: SP-101 injectionParticipants 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 | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-101 injectionSP-101 is non-competitive antagonist against NMDA receptor and is administered by intravenous infusion. | Drug | Investigational Drug group, SP-101 injection |
| PlaceboParticipants 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 group |
Primary outcome
Treatment Emergent Adverse Events, throughout study completion
Time frame: Through study completion, an average of 10 days for SAD and an average of 28 days for MAD
7 secondary outcomes
Pharmacokinetic Parameter-AUC₀-inf
Time frame: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-AUC₀-last
Time frame: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-Cmax
Time frame: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-Tmax
Time frame: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-T½
Time frame: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter-CL
Time frame: From 0 hour before dosing to 72 hours after dosing
Pharmacokinetic Parameter- Vz
Time frame: From 0 hour before dosing to 72 hours after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- WHO website has shared some Background informationLink provided by the sponsor.
- Data and information of the marketed drug (Spravato), the same targeting at NMDAR, have been key reference for study design of this protocol.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Major Depressive Disorder, Healthy Volunteer
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
RecruitingPhase 2
Neurobiology of Suicide
Healthy Volunteers, Depression
Recruiting
Exploring the Role of the Prefrontal Cortex in Decision-Making
Depressive Disorder, Major Depressive Disorder, Healthy Volunteer
Active, not recruitingPhase 1
A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
Major Depressive Disorder (MDD)
Not yet recruitingPhase 1/2
Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder
Major Depression, Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP-101 injection in people with Major Depressive Disorder, Healthy Volunteer, run by Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HECHUN WANG (+8613911873347, hechunwang@synphatec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events, throughout study completion (time frame: Through study completion, an average of 10 days for SAD and an average of 28 days for MAD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.