RecruitingEarly Phase 1

A Clinical Study of SPH7854 Granules in Healthy Subjects.

China111 participantsStarted 2024-05-28

Plain-language summary

To evaluate the safety of SPH7854 in healthy subjects.

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；
✓. Healthy volunteers;
✓. Before receiving the investigational drug, the examination results were normal or clinically insignificant;
✓. 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.

✕. Female subjects who are breastfeeding or have positive pregnancy results;
✕. Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;
✕. Subjects suffering from allergic diseases or having a history of severe allergies;
✕. Subjects who took the drug or food prohibited by the protocol prior to the first dose;
✕. Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;
✕. Other circumstances that meet the protocol exclusion criteria.

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Approximately 2 years

NCT IDNCT06483373

SponsorShanghai Pharmaceuticals Holding Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Qin Yu