A Clinical Study of SPH7854 Granules in Healthy Subjects.

Shanghai Pharmaceuticals

Status and phase: Enrolling; Early Phase 1

Conditions: Inflammatory Bowel Disease

Treatments: Drug: Placebo; Drug: SPH7854

Study type: Interventional

Funder types: Industry

Identifiers

NCT06483373

SPH7854-101

Details and patient eligibility

About

To evaluate the safety of SPH7854 in healthy subjects.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

111 participants in 2 patient groups, including a placebo group

SPH7854

Experimental group

Treatment:

Drug: SPH7854

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo