Healthy ParticipantsPhase 1NCT06839131
A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.
A Phase 1 study testing SPH9788 in people with Healthy Participants, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SPH9788
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 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
- Healthy male and female subjects aged from 18 to 45 years;
- 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;;
- Subjects who voluntarily participate and sign informed consent form;
- Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;
- Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.
Who cannot join
- Medical history (current or past) that in the investigator's judgment may interfere with trial participation;
- Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;
- Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;
- Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
- Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
- Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;
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- Substance abuse history within 1 year prior to screening or positive urine drug screen;
- Alcohol abuse history within 1 year or positive alcohol breath test;
- Smoking ≥5 cigarettes/day on average during 3 months prior to screening;
- Pregnant or lactating women;
- 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;
- Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.
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, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Huafang Li
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SPH9788 Tablet in Chinese Healthy Subjects.
The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.
- Conditions
- Healthy Participants
- Being tested
- SPH9788, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH9788Drug
SPH9788 tablets administered orally
PlaceboDrug
Matching placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| SPH9788 | Experimental | Not described Receives: Drug: SPH9788 |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Measured: Approximately 1 year
Secondary outcomes (3)
PK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
Measured: Approximately 1 year
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
Measured: Approximately 1 year
PK(Pharmacokinetics):AUC
Area under the plasma concentration versus time curve (AUC)
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start2 Mar 2025
- Primary completion31 Dec 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 Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839131
- Sponsor's protocol ID
- SPH9788-101
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SPH9788 Tablet in Chinese Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06839131
- Acronym / sponsor ID
- SPH9788-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2025 (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 purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPH9788 | Experimental | Drug: SPH9788 |
| Placebo Comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects aged from 18 to 45 years;
- 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;;
- Subjects who voluntarily participate and sign informed consent form;
- Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;
- Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.
Key exclusion criteria (12 listed)
- Medical history (current or past) that in the investigator's judgment may interfere with trial participation;
- Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;
- Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;
- Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
- Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
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 |
|---|---|---|
| SPH9788SPH9788 tablets administered orally | Drug | SPH9788 |
| PlaceboMatching placebo administered orally | Drug | Placebo Comparator |
Primary outcome
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Time frame: Approximately 1 year
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
3 secondary outcomes
PK(Pharmacokinetics):Tmax
Time frame: Approximately 1 year
PK(Pharmacokinetics):Cmax
Time frame: Approximately 1 year
PK(Pharmacokinetics):AUC
Time frame: Approximately 1 year
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 5 May 2026.
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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 SPH9788 in people with Healthy Participants, run by Shanghai Pharmaceuticals Holding 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 May 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 Huafang Li (0086-021-34773308, smhcirb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). (time frame: Approximately 1 year). 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 5 May 2026.