RecruitingEarly Phase 1NCT06483373

A Clinical Study of SPH7854 Granules in Healthy Subjects.

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.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Enrollment

111 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Disease

Summary

To evaluate the safety of SPH7854 in healthy subjects.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

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 Criteria5

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;

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