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Recruiting Early Phase 1

A Clinical Study of SPH7854 Granules in Healthy Subjects.

NCT06483373 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2024-05-28
Last updated
2026-05-05

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

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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)

FacilityCityRegionStatus
West China Second University Hospital, Sichuan University Chengdu China Recruiting
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