A Clinical Study of SPH7854 Granules in Healthy Subjects.

Early Phase 1

Recruiting

• Conditions: Inflammatory Bowel Disease
• Interventions: Drug: SPH7854; Drug: Placebo

• Registration Number: NCT06483373
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

To evaluate the safety of SPH7854 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-28
• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPH7854	SPH7854	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Approximately 2 years	Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Name	Time	Method
PK(Pharmacokinetics):Tmax	Approximately 2 years	Time to peak plasma concentration (Tmax)
PK(Pharmacokinetics):AUC	Approximately 2 years	Area under the plasma concentration versus time curve (AUC)
PK(Pharmacokinetics):Cmax	Approximately 2 years	Maximum serum concentration(Cmax)

Trial Locations

Locations (1)

West China Second University Hospital, Sichuan University; 🇨🇳 Chengdu, China