A Study of YP05002 in Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYaopharma Co., Ltd.

About this trial

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants

Eligibility criteria

Qualifiers

Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race.

In good health as determined by the Investigator, with no clinically significant findings from medical/psychiatric history, physical examination, 12-lead ECG, vital signs measurements, clinical laboratory evaluations.

Disqualifiers

Have evidence of any clinically significant active or chronic disease.

Histories of using drug that affect drug absorption, distribution, metabolism, or excretion within 14 days or within 5-half-life prior to the first dose (whichever is longer); gastrointestinal disorders with impaired gastric emptying; or prolonged use of medications that directly modulate gastrointestinal motility.

Had clinically relevant acute or chronic medical conditions or diseases that would pose a risk to participant's safety or interfere with the study assessments, as determined by the Investigator.

Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.

Trial design

Treatments tested in this trial

  • YP05002
  • Placebo

Treatment groups

76 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators