A Clinical Study of SPH7854 Granules in Healthy Subjects.
ConditionInflammatory Bowel Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Pharmaceuticals Holding Co., Ltd
About this trial
To evaluate the safety of SPH7854 in healthy subjects.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SPH7854
- Placebo
Treatment groups
111 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov