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.

SPH7854-101

To evaluate the safety of SPH7854 in healthy subjects.

2024-05-28

2025-12-31

2025-12-31

Recruiting

Early phase I

111

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 111, 'type': 'ESTIMATED'}}

2024-07-02