Evaluating SPH7854 Granules in Healthy Individuals
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.
Run by Shanghai Pharmaceuticals Holding Co., Ltd · NCT06483373 · Data updated 2026-11-12
This study is testing the safety of SPH7854 granules in healthy people to see if there are any side effects compared to a placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 111 (estimated) |
| Sponsor | Shanghai Pharmaceuticals Holding Co., Ltd Industry-sponsored |
| Locations | 1 site (Chengdu) |
| Status | Recruiting |
| Started | May 28, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06483373 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy volunteers who are not planning to conceive and can commit to effective contraceptive measures.
✕Probably not a fit
Patients with chronic diseases, severe allergies, or those who are pregnant or breastfeeding will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study aims to assess the safety of SPH7854 granules in healthy subjects. Participants will receive either the investigational drug or a placebo to determine any potential side effects. The study focuses on ensuring that volunteers meet specific health criteria and are fully informed about the trial. By monitoring the health of participants, researchers hope to gather valuable data on the safety profile of SPH7854.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety of SPH7854, potentially leading to new treatment options for inflammatory bowel disease.
How similar studies have gone: While this study focuses on a specific investigational drug, similar studies evaluating the safety of new treatments in healthy subjects have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; 2. Healthy volunteers; 3. Before receiving the investigational drug, the examination results were normal or clinically insignificant; 4. 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. Exclusion Criteria: 1. Female subjects who are breastfeeding or have positive pregnancy results; 2. Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent; 3. Subjects suffering from allergic diseases or having a history of severe allergies; 4. Subjects who took the drug or food prohibited by the protocol prior to the first dose; 5. Subjects with evidence of infection who could not be enrolled according to the investigator's judgement; 6. Other circumstances that meet the protocol exclusion criteria.
Where it's running
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West China Second University Hospital, Sichuan University
Chengdu, China Recruiting
Study contacts
- Study coordinator: Qin Yu
- Email: hxeyyb@126.com
- Phone: 0086-028-85501685
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.