RecruitingPhase 1NCT07089823

A Study of YP05002 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YP05002 in Healthy Participants


Sponsor

Yaopharma Co., Ltd.

Enrollment

76 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria5

  • 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.
  • Diagnosis of any type of pancreatitis.

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Interventions

DRUGYP05002

Tablet, QD

OTHERPlacebo

Tablet, QD


Locations(1)

Nucleus Network Melbourne Clinic

Melbourne, Victoria, Australia

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NCT07089823


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