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OpenTrials
Completed

NCT Number: NCT07089823

A Study of YP05002 in Healthy Participants

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

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Key information

Conditions

Weight Management

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Melbourne Clinic

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

YP05002

Drug

Tablet, QD

Placebo

Other

Tablet, QD

Primary outcomes

  1. Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)

    Time frame: Up to Day 14

  2. Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD)

    Time frame: Up to Day 41

Secondary outcomes

  1. Cmax of YP05002 (SAD)

    Time frame: Up to Day 14

    PK parameters of YP05002

  2. Cmax of YP05002 (MAD)

    Time frame: Up to Day 41

    PK parameters of YP05002

Sponsors and collaborators

Lead sponsor

Yaopharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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