Evaluating SPH7854 Granules in Healthy Individuals
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.
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 |
| Enrollment | 111 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Shanghai Pharmaceuticals Holding Co., Ltd Industry-sponsored |
| Locations | 1 site (Chengdu) |
| Trial ID | NCT06483373 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy volunteers who are not planning to conceive and can commit to effective contraceptive measures.
Not a fit: Patients with chronic diseases, severe allergies, or those who are pregnant or breastfeeding will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chengdu
- West China Second University Hospital, Sichuan University — Chengdu, China (Recruiting)
Study contacts
- Study coordinator: Qin Yu
- Email: hxeyyb@126.com
- Phone: 0086-028-85501685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.