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
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
Treatments tested in this trial
- SPH9788
- Placebo
Treatment groups
94 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov