Weight Management
Conditions
Brief 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
Interventions
DRUGYP05002
Tablet, QD
OTHERPlacebo
Tablet, QD
Sponsors
Yaopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. 2. Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race. 3. 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
1. Have evidence of any clinically significant active or chronic disease. 2. 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. 3. 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. 4. Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years. 5. Diagnosis of any type of pancreatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD) | Up to Day 14 |
| Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD) | Up to Day 41 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of YP05002 (SAD) | Up to Day 14 | PK parameters of YP05002 |
| Cmax of YP05002 (MAD) | Up to Day 41 | PK parameters of YP05002 |
Countries
Australia
Outcome results
None listed