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New drug SPH9788 begins first human safety tests

NCT ID NCT06839131

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing the safety of a new drug called SPH9788 in 94 healthy Chinese adults aged 18 to 45. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and how the drug moves through the body. The goal is simply to see if it is safe enough to study further—not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPH9788 tablet

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male and female subjects aged from 18 to 45 years; 2. Subject has a Body Mass Index (BMI) between 18.5 and 28.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;; 3. Subjects who voluntarily participate and sign informed consent form; 4. Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure; 5. Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion. Exclusion Criteria: 1. Medical history (current or past) that in the investigator's judgment may interfere with trial participation; 2. Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks; 3. Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration; 4. Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing; 5. Known hypersensitivity to any component of the investigational product or history of severe allergic reactions; 6. Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction; 7. Substance abuse history within 1 year prior to screening or positive urine drug screen; 8. Alcohol abuse history within 1 year or positive alcohol breath test; 9. Smoking ≥5 cigarettes/day on average during 3 months prior to screening; 10. Pregnant or lactating women; 11. Positive pregnancy test before study drug administration, or male and female subjects who refuse to use effective contraceptive methods during and for 6 months post-trial, or who have plans to donate sperm or eggs; 12. Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Mental Health Center

    RECRUITING

    Shanghai, China

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