Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SPH7854

    Drug

    SPH7854： Orally, 50-3200mg

  • Placebo

    Drug

    Placebo：Orally；

Treatment groups

111 Participants
are divided into 2 treatment groups
Group A: SPH7854Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Approximately 2 years

Secondary outcomes

1

PK(Pharmacokinetics):Tmax

Time to peak plasma concentration (Tmax)

Time frame
Approximately 2 years
2

PK(Pharmacokinetics):Cmax

Maximum serum concentration(Cmax)

Time frame
Approximately 2 years
3

PK(Pharmacokinetics):AUC

Area under the plasma concentration versus time curve (AUC)

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pharmaceuticals Holding Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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