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Recruiting NCT06483373

A Clinical Study of SPH7854 Granules in Healthy Subjects.

Early Phase I Interventional Inflammatory Bowel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPH7854, Placebo.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

To evaluate the safety of SPH7854 in healthy subjects.

Interventions

  • Drug SPH7854
    SPH7854： Orally, 50-3200mg
  • Drug Placebo
    Placebo：Orally；

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Approximately 2 years]
Secondary outcome measures (3)
  • PK(Pharmacokinetics):Tmax [Time frame: Approximately 2 years]
  • PK(Pharmacokinetics):Cmax [Time frame: Approximately 2 years]
  • PK(Pharmacokinetics):AUC [Time frame: Approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Second University Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT06483373 · SPH7854-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗