Clinical Trials in China / NCT06483373
Recruiting
Early Phase 1
A Clinical Study of SPH7854 Granules in Healthy Subjects.
NCT06483373 · tracked via the Priya Life Science China tracker
Condition(s) studied
Inflammatory Bowel Disease
Investigational drug(s) / intervention(s)
SPH7854Placebo
SPH7854: SPH7854: Orally, 50-3200mg
Placebo: Placebo:Orally;
Study summary
To evaluate the safety of SPH7854 in healthy subjects.
Eligibility
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.
Primary outcome measure(s)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| West China Second University Hospital, Sichuan University | Chengdu | China | Recruiting |
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Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06483373 on ClinicalTrials.gov ↗ ← All trials in China