Status:
RECRUITING
A Clinical Study of SPH7854 Granules in Healthy Subjects.
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
To evaluate the safety of SPH7854 in healthy subjects.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT06483373
Start Date
May 28 2024
End Date
December 31 2025
Last Update
August 17 2025
Active Locations (1)
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1
West China Second University Hospital, Sichuan University
Chengdu, China