Inflammatory Bowel DiseaseEarly Phase 1NCT06483373
A Clinical Study of SPH7854 Granules in Healthy Subjects.
A Early Phase 1 study testing SPH7854 in people with Inflammatory Bowel Disease, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
To evaluate the safety of SPH7854 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
- Inflammatory Bowel Disease
- What is being tested?
- SPH7854
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2024to 31 Dec 2026
- Phase
- Early 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
- Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；
- Healthy volunteers;
- Before receiving the investigational drug, the examination results were normal or clinically insignificant;
- Subjects who have no fertility plan/sperm donation/egg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing.
Who cannot join
- Female subjects who are breastfeeding or have positive pregnancy results;
- Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;
- Subjects suffering from allergic diseases or having a history of severe allergies;
- Subjects who took the drug or food prohibited by the protocol prior to the first dose;
- Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;
- Other circumstances that meet the protocol exclusion criteria.
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
West China Second University Hospital, Sichuan University
Chengdu
Qin Yu
About this study
Official title: A Single and Multiple Dose-escalation, and Food Effects of Phase I Clinical Study to Evaluate the Tolerability/Safety/Pharmacokinetics of SPH7854 Granules in Healthy Subjects.
To evaluate the safety of SPH7854 in healthy subjects.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- SPH7854, Placebo
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH7854Drug
SPH7854： Orally, 50-3200mg
PlaceboDrug
Placebo：Orally；
| Study group | Role | What they receive |
|---|---|---|
| SPH7854 | Experimental | Not described Receives: Drug: SPH7854 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 2 years
Secondary outcomes (3)
PK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
Measured: Approximately 2 years
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
Measured: Approximately 2 years
PK(Pharmacokinetics):AUC
Area under the plasma concentration versus time curve (AUC)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start28 May 2024
- 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 Inflammatory Bowel DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 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
- NCT06483373
- Sponsor's protocol ID
- SPH7854-101
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2024
- 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 Single and Multiple Dose-escalation, and Food Effects of Phase I Clinical Study to Evaluate the Tolerability/Safety/Pharmacokinetics of SPH7854 Granules in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06483373
- Acronym / sponsor ID
- SPH7854-101
- Conditions
- Inflammatory Bowel Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
To evaluate the safety of SPH7854 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPH7854 | Experimental | Drug: SPH7854 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；
- Healthy volunteers;
- Before receiving the investigational drug, the examination results were normal or clinically insignificant;
- Subjects who have no fertility plan/sperm donation/egg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing.
Key exclusion criteria (6 listed)
- Female subjects who are breastfeeding or have positive pregnancy results;
- Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;
- Subjects suffering from allergic diseases or having a history of severe allergies;
- Subjects who took the drug or food prohibited by the protocol prior to the first dose;
- Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;
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 |
|---|---|---|
| SPH7854SPH7854： Orally, 50-3200mg | Drug | SPH7854 |
| PlaceboPlacebo：Orally； | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
3 secondary outcomes
PK(Pharmacokinetics):Tmax
Time frame: Approximately 2 years
PK(Pharmacokinetics):Cmax
Time frame: Approximately 2 years
PK(Pharmacokinetics):AUC
Time frame: Approximately 2 years
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 Early Phase 1 study testing SPH7854 in people with Inflammatory Bowel Disease, 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 4 inclusion and 6 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Qin Yu (0086-028-85501685, hxeyyb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Approximately 2 years). 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.