Health TrialsbyHealthPanel

A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Pharmaceuticals Holding Co., Ltd

About this trial

The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male and female subjects aged from 18 to 45 years;

Subject has a Body Mass Index (BMI) between 18.5 and 28.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;;

Subjects who voluntarily participate and sign informed consent form;

Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;

Disqualifiers

Medical history (current or past) that in the investigator's judgment may interfere with trial participation;

Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;

Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;

Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;

Trial design

Design model

Sequential

Treatments tested in this trial

  • SPH9788

    Drug

    SPH9788 tablets administered orally

  • Placebo

    Drug

    Matching placebo administered orally

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: SPH9788Experimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

(一) 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 1 year

Secondary outcomes

1

PK(Pharmacokinetics):Tmax

Time to peak plasma concentration (Tmax)

Time frame
Approximately 1 year
2

PK(Pharmacokinetics):Cmax

Maximum serum concentration(Cmax)

Time frame
Approximately 1 year
3

PK(Pharmacokinetics):AUC

Area under the plasma concentration versus time curve (AUC)

Time frame
Approximately 1 year

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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