An Early Phase 1 interventional study of SPH7854 and Placebo in Inflammatory Bowel Disease, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd · Early Phase 1, Interventional, and Treatment
Among 112 studies in Inflammatory Bowel Diseases with a site in China — 50 open to participants now, 54 under way, 5 of them phase 3. Inflammatory Bowel Diseases · China.
Among the 112 studies in Inflammatory Bowel Diseases with a site in China, this one is the 21st largest by planned enrollment of the 58 interventional ones that give a count, is one of 12 that started in 2024, is one of 13 in phase 1, reaches primary completion later than 28 of the 53 other live ones, and was the 65th registered.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
Browse Inflammatory Bowel Diseases studies →50 of the 112 studies in Inflammatory Bowel Diseases with a site in China are open now. Recruiting first, the newest first:
Jie Liang · Sites in China
Benethera (Shaoxing) Biotechnology Co., Ltd. · Sites in China
Second Affiliated Hospital, School of Medicine, Zhejiang University · Sites in China
First Affiliated Hospital of Kunming Medical University · Sites in China
Changhai Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 278 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 118 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
112 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 12 · Phase 3 9
First in 2009; this study’s year is marked. 12 started in 2024.
This study's planned enrollment of 111 is above the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Median enrollment 97 across the 58 interventional studies, 148 across the 54 observational. Of the 34 that completed or were terminated, 6 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 112 have an industry lead sponsor. The 10 most frequent:
Shanghai Pharmaceuticals Holding Co., Ltd is the lead sponsor of 35 studies on the registry; 14 are open to participants now.
Shanghai Pharmaceuticals Holding Co., Ltd has 1 study filed under Inflammatory Bowel Diseases — fewer than ten, so there is no comparison to draw.
12 of the studies in Inflammatory Bowel Diseases with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06713694Wang ZhenThe Impact of Culture in Cognitive Behavior Therapy (CBT) for Patients With Inflammatory Bowel Disease | 2026-12-30 |
| NCT07632573Benethera (Shaoxing) Biotechnology Co., Ltd.A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult | 2026-12-31 |
| NCT07165470Changhai HospitalPre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease | 2026-12-31 |
| NCT06483373Shanghai Pharmaceuticals Holding Co., LtdA Clinical Study of SPH7854 Granules in Healthy Subjects. | 2026-12-31 |
| NCT04187820Shanghai Institute of Acupuncture, Moxibustion and MeridianEffect of Acupuncture on Mild to Moderate Active Crohn's Disease | 2026-12-31 |
Among the 112 studies in Inflammatory Bowel Diseases with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To evaluate the safety of SPH7854 in healthy subjects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SPH7854
Drug: Placebo
SPH7854： Orally, 50-3200mg
Placebo：Orally；
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 2 years
PK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
Time frame: Approximately 2 years
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
Time frame: Approximately 2 years
PK(Pharmacokinetics):AUC
Area under the plasma concentration versus time curve (AUC)
Time frame: Approximately 2 years
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.
Of 35 industry-sponsored phase 1 interventional studies under Inflammatory Bowel Diseases, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's planned 31 months is above that.
Counting every sponsor, half of 51 studies reached it within 12 months; a quarter within 4 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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Shanghai Pharmaceuticals Holding Co., Ltd →